The following data is part of a premarket notification filed by Woodlyn, Inc. with the FDA for Woodlyn Operation Microscope.
| Device ID | K931303 |
| 510k Number | K931303 |
| Device Name: | WOODLYN OPERATION MICROSCOPE |
| Classification | Microscope, Surgical, General & Plastic Surgery |
| Applicant | WOODLYN, INC. 2920 MALMO DR. Arlington Heights, IL 60005 -4726 |
| Contact | Ronald Nielsen |
| Correspondent | Ronald Nielsen WOODLYN, INC. 2920 MALMO DR. Arlington Heights, IL 60005 -4726 |
| Product Code | FSO |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-15 |
| Decision Date | 1993-06-25 |