Submission Details
| 510(k) Number | K852993 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 15, 1985 |
| Decision Date | August 07, 1985 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
K852993 - BONE RONGEURS
(FDA 510(k) Clearance)
Aug 1985
Decision
23d
Days
—
Risk
K852993 is an FDA 510(k) clearance for the BONE RONGEURS, submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on August 7, 1985, 23 days after receiving the submission on July 15, 1985. This device falls under the General & Plastic Surgery review panel.
Device Classification
| Product Code | — |
| Device Class | — |