The following data is part of a premarket notification filed by Snowden-pencer with the FDA for Reusable Laparoscopic Instruments W/ Electrocautery.
Device ID | K930666 |
510k Number | K930666 |
Device Name: | REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | SNOWDEN-PENCER 2058 KILMAN DR. Tucker, GA 30084 |
Contact | Norman M Black |
Correspondent | Norman M Black SNOWDEN-PENCER 2058 KILMAN DR. Tucker, GA 30084 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-09 |
Decision Date | 1994-05-19 |