The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Wire Cutting Pliers Or Lineman's Pliers.
Device ID | K854390 |
510k Number | K854390 |
Device Name: | WIRE CUTTING PLIERS OR LINEMAN'S PLIERS |
Classification | Pliers, Surgical |
Applicant | MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
Contact | John M Mayerik |
Correspondent | John M Mayerik 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 | 1985-10-31 |
Decision Date | 1985-11-19 |