K121953 is an FDA 510(k) clearance for the HEMASORB APPLY. This device is classified as a Wax, Bone.
Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on November 21, 2012, 141 days after receiving the submission on July 3, 2012.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K121953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2012 |
| Decision Date | November 21, 2012 |
| Days to Decision | 141 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MTJ — Wax, Bone |
| Device Class | — |