Sterile Plastic Dressing
FDA 510(k) K944588 · Smith & Nephew, Inc.
510(k) numberK944588
Submission
- Device name
- Sterile Plastic Dressing
- Applicant
- Smith & Nephew, Inc.
Quebec, CA - Received
- September 19, 1994
- Decision date
- November 7, 1994
- 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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| 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 |
| 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 |
| K940798 | Shippert Pressure BandageKGX · Traditional | Denver Splint Co. | 09/28/1994SE |
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Questions and answers
When was Sterile Plastic Dressing cleared by the FDA?
Sterile Plastic Dressing (K944588) received a 510(k) decision of Substantially Equivalent on November 7, 1994, 49 days after the submission was received.
What is the product code of K944588?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.