The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Model 8700 Bipolar Electrosurgical Generator.
Device ID | K870981 |
510k Number | K870981 |
Device Name: | MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | EVEREST MEDICAL CORP. 6601 SHINGLE CREEK PKWY. SUITE 400 Brooklyn Center, MN 55430 |
Contact | Dwayne K Buchholz |
Correspondent | Dwayne K Buchholz EVEREST MEDICAL CORP. 6601 SHINGLE CREEK PKWY. SUITE 400 Brooklyn Center, MN 55430 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-10 |
Decision Date | 1987-05-06 |