Primaderm
FDA 510(k) K854740 · Absorbent Cotton Co., Inc.
510(k) numberK854740
Submission
- Device name
- Primaderm
- Applicant
- Absorbent Cotton Co., Inc.
Hammonton, NJ, US - Received
- November 25, 1985
- Decision date
- March 14, 1986
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAD – Dressing, Wound, Occlusive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 09/10/2026SE |
| K102403 | Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional | Sam Medical Products | 03/03/2011SE |
| K091133 | Aplion Topical Care SystemNAD · Traditional | Aplion Medical,Llc | 05/20/2009SE |
| K072560 | Envela (Hydrohesive Occlusive Dressing)NAD · Traditional | Teikoku Pharma USA, Inc. | 06/17/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | Tri-State Hospital Supply Corp. | 04/23/2008SE |
| K060046 | DermastreamNAD · Traditional | Enzysurge , Ltd. | 02/27/2006SE |
| K043063 | Oxyband Wound DressingNAD · Traditional | Oxyband Technologies, Inc. | 03/24/2005SE |
| K020781 | Wet ChamberNAD · Traditional | Kinetic Concepts, Inc. | 05/06/2002SE |
| K990530 | Kerlix MD Antimicrobial Gauze DressingNAD · Traditional | The Kendall Company, L.P. | 01/31/2000SE |
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | Hospital Specialty Co. | 04/12/1999SE |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K883250 | Steri-Clens Wound Care KitLRO · Traditional | 08/26/1988SE |
| K880613 | Acco(R) Face MaskFXX · Traditional | 03/04/1988SE |
| K875129 | Steri-ClensGEC · Traditional | 02/18/1988SE |
| K874741 | Steri-Clens(Tm) Surgical Scrub SpongeGEC · Traditional | 12/10/1987SE |
| K873523 | Plain Dry GauzeEFQ · Traditional | 10/09/1987SE |
| K850126 | Oil Emulsion Non-Adhering DressingFRO · Traditional | 04/25/1985SE |
| K844095 | Wet Dressing Water-SterileNAD · Traditional | 11/27/1984SE |
| K844096 | Wet Dressing Saline-SterileFRO · Traditional | 11/19/1984SE |
| K781727 | Change in Sterilization ProcedureGOY · Traditional | 12/04/1978SE |
Questions and answers
When was Primaderm cleared by the FDA?
Primaderm (K854740) received a 510(k) decision of Substantially Equivalent for Some Indications on March 14, 1986, 109 days after the submission was received.
What is the product code of K854740?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.