Submission Details
| 510(k) Number | K933228 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 02, 1993 |
| Decision Date | March 30, 1994 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
Cleared
Traditional
KAPTON PEEL POUCH
Mar 1994
Decision
271d
Days
Class 1
Risk
About This 510(k) Submission
K933228 is an FDA 510(k) clearance for the KAPTON PEEL POUCH, a Flask, Tissue Culture (Class I — General Controls, product code KJA), submitted by American Fluoroseal Corp. (Silver Spring, US). The FDA issued a Cleared decision on March 30, 1994, 271 days after receiving the submission on July 2, 1993. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.
Device Classification
| Product Code | KJA — Flask, Tissue Culture |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.2240 |
Manufacturer
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