The following data is part of a premarket notification filed by William E. Mckay with the FDA for Model 6400 Abc Electrosurgery Generator.
Device ID | K933332 |
510k Number | K933332 |
Device Name: | MODEL 6400 ABC ELECTROSURGERY GENERATOR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | WILLIAM E. MCKAY 6110 BOLLINGER RD. San Jose, CA 95129 |
Contact | William E Mckay |
Correspondent | William E Mckay WILLIAM E. MCKAY 6110 BOLLINGER RD. San Jose, CA 95129 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-08 |
Decision Date | 1993-09-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30653405002141 | K933332 | 000 |
10653405002147 | K933332 | 000 |