The following data is part of a premarket notification filed by Syntech Mfg. Services with the FDA for Protecto-shield.
| Device ID | K881913 |
| 510k Number | K881913 |
| Device Name: | PROTECTO-SHIELD |
| Classification | Mask, Surgical |
| Applicant | SYNTECH MFG. SERVICES 1501 E CHAPMAN SUITE 352 Fullerton, CA 92631 |
| Contact | Nick Herbert |
| Correspondent | Nick Herbert SYNTECH MFG. SERVICES 1501 E CHAPMAN SUITE 352 Fullerton, CA 92631 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-09 |
| Decision Date | 1988-07-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PROTECTO-SHIELD 73091269 1084432 Dead/Cancelled |
Femco, Inc. 1976-06-23 |
![]() PROTECTO-SHIELD 71474971 0420366 Live/Registered |
WILLSON PRODUCTS, INC. 1944-10-05 |