Submission Details
| 510(k) Number | K822990 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 12, 1982 |
| Decision Date | April 12, 1983 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
CONVERTORS PRIMARY WOUND DRESSING II
Apr 1983
Decision
182d
Days
—
Risk
About This 510(k) Submission
K822990 is an FDA 510(k) clearance for the CONVERTORS PRIMARY WOUND DRESSING II, a Dressing, Wound, Drug, submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983, 182 days after receiving the submission on October 12, 1982. This device falls under the General & Plastic Surgery review panel.
Device Classification
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |
Manufacturer
Similar Devices — FRO Dressing, Wound, Drug
All 698
K251999 · Solventum Germany GmbH
· Mar 2026
K252028 · Huizhou Foryou Medical Co., Ltd.
· Mar 2026
K251582 · Beijing Kreate Medical Co., Ltd.
· Feb 2026
K252568 · Silk Holdings, Inc.
· Jan 2026
K250890 · Sioxmed, LLC
· Jan 2026
K252759 · Kane Biotech, Inc.
· Jan 2026
More from American Hospital Supply Corp.
View all
K854739
· Dec 1985
K854759
· Dec 1985
K832826
· FNY · Apr 1984
K830546
· KQT · May 1983
K830343
· KDP · Mar 1983