Comfeel Powder
FDA 510(k) K834343 · Coloplast A/S
510(k) numberK834343
Submission
- Device name
- Comfeel Powder
- Applicant
- Coloplast A/S
Walker, MI, US - Received
- December 12, 1983
- Decision date
- November 8, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOZ – Beads, Hydrophilic, For Wound Exudate Absorption
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4018
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905206 | Incare Pinsite DressingKOZ · Traditional | Hollister, Inc. | 04/12/1991SE |
| K905688 | Cutinova HydroKOZ · Traditional | Beiersdorf, Inc. | 04/01/1991SE |
| K905069 | Iodosorb GelKOZ · Traditional | Perstorp AB C/O Robert Joel Slomoff | 01/31/1991SE |
| K904604 | Redi-Release Absorbent DressingKOZ · Traditional | Fountain Pharmaceuticals, Inc. | 01/07/1991SE |
| K903645 | Dermasorb Wound Contact Layer DressingKOZ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 11/21/1990SE |
| K896828 | Bioclusive(R) Absorbent DressingKOZ · Traditional | Johnson & Johnson International | 11/21/1990SE |
| K904412 | Allevyn Dressing Claims ChangeKOZ · Traditional | Smith & Nephew United, Inc. | 10/23/1990SN |
| K901876 | Intrasite Cavity Wound Dressing (Label Revision)KOZ · Traditional | Smith & Nephew United, Inc. | 06/28/1990SN |
| K896176 | Exusorb(Tm) Dry/Wet DressingKOZ · Traditional | Controlled Therapeutics Corp. | 11/24/1989SE |
| K895354 | Intrasite Cavity Wound DressingKOZ · Traditional | Smith & Nephew United, Inc. | 11/07/1989SN |
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Questions and answers
When was Comfeel Powder cleared by the FDA?
Comfeel Powder (K834343) received a 510(k) decision of Substantially Equivalent on November 8, 1984, 332 days after the submission was received.
What is the product code of K834343?
The FDA product code is KOZ – Beads, Hydrophilic, For Wound Exudate Absorption, a Class I (low risk) device regulated under 21 CFR 878.4018.