Submission Details
| 510(k) Number | K905069 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 09, 1990 |
| Decision Date | January 31, 1991 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
IODOSORB GEL
Jan 1991
Decision
83d
Days
Class 1
Risk
About This 510(k) Submission
K905069 is an FDA 510(k) clearance for the IODOSORB GEL, a Beads, Hydrophilic, For Wound Exudate Absorption (Class I — General Controls, product code KOZ), submitted by Perstorp AB C/O Robert Joel Slomoff (Potomac, US). The FDA issued a Cleared decision on January 31, 1991, 83 days after receiving the submission on November 9, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4018.
Device Classification
| Product Code | KOZ — Beads, Hydrophilic, For Wound Exudate Absorption |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4018 |
Manufacturer
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