K792629 is an FDA 510(k) clearance for the STERILIZATION PROCESS/T-BINDER. This device is classified as a Binder, Elastic (Class I - General Controls, product code KMO).
Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980, 23 days after receiving the submission on December 19, 1979.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5160.
| 510(k) Number | K792629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1979 |
| Decision Date | January 11, 1980 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KMO — Binder, Elastic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5160 |