The following data is part of a premarket notification filed by Microsurge, Inc. with the FDA for Microsurge Laser Fiber With Sma Connector.
Device ID | K914175 |
510k Number | K914175 |
Device Name: | MICROSURGE LASER FIBER WITH SMA CONNECTOR |
Classification | Powered Laser Surgical Instrument |
Applicant | MICROSURGE, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
Contact | Lynne Aronson |
Correspondent | Lynne 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 | 1991-09-18 |
Decision Date | 1991-12-17 |