The following data is part of a premarket notification filed by Boston Surgical Products, Inc. with the FDA for Electrosurgical Endoscopic Cord.
Device ID | K945717 |
510k Number | K945717 |
Device Name: | ELECTROSURGICAL ENDOSCOPIC CORD |
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 | 1994-11-21 |
Decision Date | 1994-12-08 |