The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Automatic Multiclip Dispos. Ligating.
Device ID | K843336 |
510k Number | K843336 |
Device Name: | AUTOMATIC MULTICLIP DISPOS. LIGATING |
Classification | Clip, Implantable |
Applicant | DAVIS & GECK, INC. Danbury , CT 06810 - |
Contact | Pelletier |
Correspondent | Pelletier DAVIS & GECK, INC. Danbury , CT 06810 - |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-27 |
Decision Date | 1984-10-31 |