The following data is part of a premarket notification filed by Snowden-pencer with the FDA for Electrosurgical Cutting And Coagulation Accessory.
Device ID | K861372 |
510k Number | K861372 |
Device Name: | ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | SNOWDEN-PENCER 6191 ATLANTIC BLVD. Norcross, GA 30071 |
Contact | Norman Black |
Correspondent | Norman Black SNOWDEN-PENCER 6191 ATLANTIC BLVD. Norcross, GA 30071 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-11 |
Decision Date | 1986-06-19 |