K883338 is an FDA 510(k) clearance for the SURGICAL SEALANT APPLICATOR. This device is classified as a Syringe, Irrigating (non Dental) (Class I - General Controls, product code KYZ).
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 23, 1988, 14 days after receiving the submission on August 9, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6960.
| 510(k) Number | K883338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1988 |
| Decision Date | August 23, 1988 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KYZ — Syringe, Irrigating (non Dental) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6960 |