K870941 is an FDA 510(k) clearance for the PHARMASEAL WOUND CARE DRESSING PAD. This device is classified as a Beads, Hydrophilic, For Wound Exudate Absorption (Class I - General Controls, product code KOZ).
Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on March 27, 1987, 18 days after receiving the submission on March 9, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4018.
| 510(k) Number | K870941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1987 |
| Decision Date | March 27, 1987 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KOZ — Beads, Hydrophilic, For Wound Exudate Absorption |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4018 |