The following data is part of a premarket notification filed by Pilling Weck, Inc. with the FDA for Versastat Multipolar Scissors And Cables.
Device ID | K974250 |
510k Number | K974250 |
Device Name: | VERSASTAT MULTIPOLAR SCISSORS AND CABLES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | PILLING WECK, INC. 420 DELAWARE DR. Fort Washington, PA 19034 |
Contact | Richard G Jones |
Correspondent | Richard G Jones PILLING WECK, INC. 420 DELAWARE DR. Fort Washington, PA 19034 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-13 |
Decision Date | 1998-02-11 |
Summary: | summary |