K802881 is an FDA 510(k) clearance for the ABSELE* ABSORBABLE BONE SEALANT..
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1980, 32 days after receiving the submission on November 17, 1980.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K802881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1980 |
| Decision Date | December 19, 1980 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | — |
| Device Class | — |