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 |