The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Toggle Locking Pliers-straight Jaw, Curved Jaw.
Device ID | K844146 |
510k Number | K844146 |
Device Name: | TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW |
Classification | Pliers, Surgical |
Applicant | MED-TOOL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HTC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-23 |
Decision Date | 1984-11-20 |