Dale(R) Nasal Dressing Holder (Product No. 600)
FDA 510(k) K914245 · Dale Medical Products, Inc.
510(k) numberK914245
Submission
- Device name
- Dale(R) Nasal Dressing Holder (Product No. 600)
- Applicant
- Dale Medical Products, Inc.
Plainville, MA, US - Received
- September 23, 1991
- Decision date
- December 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGX – Tape And Bandage, Adhesive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Specialty
- General Hospital
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| K972914 | Syvek PatchKGX · Traditional | Marine Polymer Technologies, Inc. | 12/22/1997SE |
| K943314 | Adhesive Bandages with OTC DrugKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 01/17/1996SE |
| K952606 | Targett PatchKGX · Traditional | Cutting Edge Technologies, Inc. | 12/21/1995SE |
| K954007 | ParallelKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 11/22/1995SE |
| K944587 | Dermiview Hypoallergenic Clear TapeKGX · Traditional | Johnson & Johnson Medical, Inc. | 10/30/1995SE |
| K944588 | Sterile Plastic DressingKGX · Traditional | Smith & Nephew, Inc. | 11/07/1994SE |
| K941788 | Band-Aid Brand Adhesive Bandages, Sport StripKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
| K940536 | Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
More from Johnson & Johnson Consumer Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082241 | The Dale Ace Connector (Access Controller for Enteral), Model H84104751KNT · Traditional | 10/30/2008SE |
| K994300 | Nasogastric Tube Holder, Model 160KNT · Traditional | 02/10/2000SE |
| K964399 | Dale Endotracheal Tube Holder 270/280CBH · Traditional | 01/28/1997SE |
| K961693 | Dale Gastrostomy Tube HolderPLI · Traditional | 07/30/1996SE |
| K951491 | Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsCBH · Traditional | 04/24/1995SE |
| K905231 | Dale Ventilator Tubing Support for Trach. Vent.CBH · Traditional | 01/14/1991SE |
| K894586 | Dale I.V. Identifier; Product #1125KMK · Traditional | 08/15/1989SE |
| K873311 | Dale I.V. Connect. Lock & Stabilizer (STABILOK)220KMK · Traditional | 11/05/1987SE |
| K864897 | Dale Venipuncture Tourniquet, Product No. 1335GAX · Traditional | 01/12/1987SE |
| K860583 | Dale Head Band Anesthesia Circuit Tube Holder 1315JAY · Traditional | 02/21/1986SE |
Questions and answers
When was Dale(R) Nasal Dressing Holder (Product No. 600) cleared by the FDA?
Dale(R) Nasal Dressing Holder (Product No. 600) (K914245) received a 510(k) decision of Substantially Equivalent on December 9, 1991, 77 days after the submission was received.
What is the product code of K914245?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.