K881020 is an FDA 510(k) clearance for the SURGICAL SEALANT DISPENSER (SSD). 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 March 25, 1988, 15 days after receiving the submission on March 10, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6960.
| 510(k) Number | K881020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1988 |
| Decision Date | March 25, 1988 |
| Days to Decision | 15 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 |