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 |