K895422 is an FDA 510(k) clearance for the TOWER SELF SEAL STERILIZATION POUCH. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Baxter Healthcare Corp (Deerfield Lake, US). The FDA issued a Cleared decision on November 29, 1989, 89 days after receiving the submission on September 1, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K895422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1989 |
| Decision Date | November 29, 1989 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |