The following data is part of a premarket notification filed by Boston Surgical Products, Inc. with the FDA for Reusable Monopolar Forceps.
Device ID | K950877 |
510k Number | K950877 |
Device Name: | REUSABLE MONOPOLAR FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston, MA 02364 |
Contact | Lawrence T Kirwan, Jr. |
Correspondent | Lawrence T Kirwan, Jr. BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston, MA 02364 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-27 |
Decision Date | 1995-03-09 |