The following data is part of a premarket notification filed by Microsurge, Inc. with the FDA for Microsurge Laser Fiber Holder.
| Device ID | K912332 |
| 510k Number | K912332 |
| Device Name: | MICROSURGE LASER FIBER HOLDER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MICROSURGE, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | Lynn Aronson |
| Correspondent | Lynn Aronson MICROSURGE, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1991-08-21 |