The following data is part of a premarket notification filed by Secol Co. with the FDA for Cobbler's Chip Splints.
Device ID | K810110 |
510k Number | K810110 |
Device Name: | COBBLER'S CHIP SPLINTS |
Classification | Component, Cast |
Applicant | SECOL CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LGF |
CFR Regulation Number | 888.5940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-16 |
Decision Date | 1981-01-26 |