The following data is part of a premarket notification filed by Synthetic Mfg., Inc. with the FDA for Colored Casting Tape Caraglas(tm Green.
Device ID | K874880 |
510k Number | K874880 |
Device Name: | COLORED CASTING TAPE CARAGLAS(TM GREEN |
Classification | Component, Cast |
Applicant | SYNTHETIC MFG., INC. C/O BUCKMAN COMPANY, INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf SYNTHETIC MFG., INC. C/O BUCKMAN COMPANY, INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | LGF |
CFR Regulation Number | 888.5940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-01 |
Decision Date | 1987-12-30 |