OPERATING MICROSCOPE AA OM 10
Device Facts
| Record ID | K941399 |
|---|---|
| Device Name | OPERATING MICROSCOPE AA OM 10 |
| Applicant | Appasamy Associates (U.S.A.), Inc. |
| Product Code | FSO · General, Plastic Surgery |
| Decision Date | Apr 22, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.