K933085 is an FDA 510(k) clearance for the GOODMAN BANDAGE. This device is classified as a Bag, Intestine (Class I - General Controls, product code KGY).
Submitted by Megadyne Medical Products, Inc. (Draper, US). The FDA issued a Cleared decision on December 23, 1993, 183 days after receiving the submission on June 23, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4100.
| 510(k) Number | K933085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1993 |
| Decision Date | December 23, 1993 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGY — Bag, Intestine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4100 |