The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Valtrac (bar) Remover Device.
Device ID | K863752 |
510k Number | K863752 |
Device Name: | VALTRAC (BAR) REMOVER DEVICE |
Classification | Knife, Surgical |
Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
Contact | R. I Pelletier |
Correspondent | R. I Pelletier DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
Product Code | EMF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-25 |
Decision Date | 1986-10-24 |