The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Neo Shield.
Device ID | K852943 |
510k Number | K852943 |
Device Name: | NEO SHIELD |
Classification | Warmer, Infant Radiant |
Applicant | GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
Contact | John Phillips |
Correspondent | John Phillips GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
Product Code | FMT |
CFR Regulation Number | 880.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-11 |
Decision Date | 1985-11-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() NEO SHIELD 87087674 5254223 Live/Registered |
Surface Shields, Inc. 2016-06-29 |