510(k) K921146 ยท GEX Powered Laser Surgical Instrument
SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40
| Applicant | Sharplan Lasers, Inc., Allendale NJ, US |
| Decision | Substantially Equivalent, Jun 8, 1992 |
| Received | Mar 10, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921146
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.