The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Slip Joint Pliers.
Device ID | K844600 |
510k Number | K844600 |
Device Name: | SLIP JOINT PLIERS |
Classification | Pliers, Surgical |
Applicant | MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
Contact | John M Mayerick |
Correspondent | John M Mayerick MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
Product Code | HTC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-27 |
Decision Date | 1984-12-14 |