Wet Dressing Kit
FDA 510(k) K833075 · Clinipad Corp.
510(k) numberK833075
Submission
- Device name
- Wet Dressing Kit
- Applicant
- Clinipad Corp.
Mchenry, IL, US - Received
- September 9, 1983
- Decision date
- January 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KDD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional | Covidien | 04/16/2008SE |
| K011514 | Instruments for One Time Use - DisposableKDD · Traditional | Kencap , Ltd. | 08/13/2001SE |
| K971317 | National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional | National Healthcare Mfg. Corp. | 05/08/1997SE |
| K960456 | Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional | Denver Biomaterials, Inc. | 04/01/1996SE |
| K936255 | Custom CV PackKDD · Traditional | Associated Medical | 03/31/1994SN |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | Associated Medical Products Co. | 07/09/1993SESK |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K925905 | Kit, Surgical Instrument, DisposableKDD · Traditional | Kay Medical Concepts | 06/16/1993SESK |
| K924958 | Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional | Medical Insights, Inc. | 06/07/1993SEKD |
| K925215 | Sterile Surgical Instrument TraysKDD · Traditional | American Healthcare Supply Co., Inc. | 06/01/1993SEKD |
More from American Healthcare Supply Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931560 | Cardiac Catheterization TrayDQO · Traditional | 07/11/1994SEKD |
| K931668 | Picc Insertion TrayFOZ · Traditional | 03/07/1994SEKD |
| K932071 | I.V. Start KitFOZ · Traditional | 02/17/1994SEKD |
| K932010 | V.A.D. Access KitLJT · Traditional | 02/03/1994SE |
| K932036 | Laceration TrayFRG · Traditional | 12/13/1993SESK |
| K932016 | Tracheostomy Care TrayJOH · Traditional | 11/03/1993SE |
| K862562 | Punch Biopsy KitKNW · Traditional | 10/07/1986SE |
| K862563 | Tracheostomy Cleansing SolutionEPE · Traditional | 07/15/1986SE |
| K833432 | Catheter Insertion KitKOD · Traditional | 12/28/1983SE |
| K830476 | Or Prep KitFRG · Traditional | 03/31/1983SE |
Questions and answers
When was Wet Dressing Kit cleared by the FDA?
Wet Dressing Kit (K833075) received a 510(k) decision of Substantially Equivalent on January 27, 1984, 140 days after the submission was received.
What is the product code of K833075?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.