K960204 is an FDA 510(k) clearance for the G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by GE Medical Systems (Palm Harbor, US). The FDA issued a Cleared decision on February 27, 1996, 42 days after receiving the submission on January 16, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K960204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1996 |
| Decision Date | February 27, 1996 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |