Submission Details
| 510(k) Number | K853801 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 1985 |
| Decision Date | October 08, 1985 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
K853801 - MENISCAL STITCHING KIT
(FDA 510(k) Clearance)
Oct 1985
Decision
27d
Days
—
Risk
K853801 is an FDA 510(k) clearance for the MENISCAL STITCHING KIT, submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on October 8, 1985, 27 days after receiving the submission on September 11, 1985. This device falls under the General & Plastic Surgery review panel.
Device Classification
| Product Code | — |
| Device Class | — |