The following data is part of a premarket notification filed by T F & G Products with the FDA for The Finger Guard.
Device ID | K052619 |
510k Number | K052619 |
Device Name: | THE FINGER GUARD |
Classification | Oximeter |
Applicant | T F & G PRODUCTS 6956 ORO BANGOR HWY. Oroville, CA 95966 |
Contact | Mariruth Gurley |
Correspondent | Mariruth Gurley T F & G PRODUCTS 6956 ORO BANGOR HWY. Oroville, CA 95966 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-23 |
Decision Date | 2006-01-06 |
Summary: | summary |