The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Synthetic Cast Tape.
| Device ID | K883294 |
| 510k Number | K883294 |
| Device Name: | SYNTHETIC CAST TAPE |
| Classification | Component, Cast |
| Applicant | CARAPACE, INC. C/O BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf CARAPACE, INC. C/O BUCKMAN CO., 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 | 1988-08-04 |
| Decision Date | 1988-08-30 |