The following data is part of a premarket notification filed by Gam Industries, Inc. with the FDA for Jaw Spreader.
Device ID | K936050 |
510k Number | K936050 |
Device Name: | JAW SPREADER |
Classification | Screw, Oral |
Applicant | GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg, VA 23804 -1526 |
Contact | Gary J Beden |
Correspondent | Gary J Beden GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg, VA 23804 -1526 |
Product Code | KBW |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-20 |
Decision Date | 1994-03-24 |