The following data is part of a premarket notification filed by Microsurge, Inc. with the FDA for Microsurge Bipolar Graspers.
Device ID | K951230 |
510k Number | K951230 |
Device Name: | MICROSURGE BIPOLAR GRASPERS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MICROSURGE, INC. 150 A ST. Needham, MA 02194 |
Contact | Richard Lariviere |
Correspondent | Richard Lariviere MICROSURGE, INC. 150 A ST. Needham, MA 02194 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-20 |
Decision Date | 1995-06-14 |