| Record ID | K922401 |
|---|---|
| Device Name | 4 SURE TM COLOSTOMY POUCH |
| Applicant | Boston Pacific Medical, Inc. |
| Product Code | EZQ · Gastroenterology, Urology |
| Decision Date | Jun 10, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5900 |
| Device Class | Class 1 |
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