The following data is part of a premarket notification filed by Moeller Microsurgical, Inc. with the FDA for Moller-wedel Operating Microscope.
| Device ID | K926513 |
| 510k Number | K926513 |
| Device Name: | MOLLER-WEDEL OPERATING MICROSCOPE |
| Classification | Microscope, Surgical, General & Plastic Surgery |
| Applicant | MOELLER MICROSURGICAL, INC. 40 WOODBRIDGE AVE. Metuchen, NJ 08840 |
| Contact | Richard Montgomery |
| Correspondent | Richard Montgomery MOELLER MICROSURGICAL, INC. 40 WOODBRIDGE AVE. Metuchen, NJ 08840 |
| Product Code | FSO |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-30 |
| Decision Date | 1993-06-22 |