K920153 is an FDA 510(k) clearance for the THERMUFF BAG. This device is classified as a Instrument, Surgical, Disposable (Class I - General Controls, product code KDC).
Submitted by Techstyles (Dallas, US). The FDA issued a Cleared decision on July 1, 1992, 170 days after receiving the submission on January 13, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K920153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 1992 |
| Decision Date | July 01, 1992 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KDC — Instrument, Surgical, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |