The following data is part of a premarket notification filed by Microsurge, Inc. with the FDA for Microsurge Suction/irrigation System Cannulas.
Device ID | K930355 |
510k Number | K930355 |
Device Name: | MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULAS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MICROSURGE, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
Contact | Mary Mcnamara |
Correspondent | Mary Mcnamara MICROSURGE, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-25 |
Decision Date | 1993-06-08 |