The following data is part of a premarket notification filed by Linemaster Switch Corp. with the FDA for Ir Wireless Foot Switch.
Device ID | K053510 |
510k Number | K053510 |
Device Name: | IR WIRELESS FOOT SWITCH |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | LINEMASTER SWITCH CORP. 29 PLAINE HILL ROAD Woodstock, CT 06281 |
Contact | Mike Szostek |
Correspondent | Mike Szostek LINEMASTER SWITCH CORP. 29 PLAINE HILL ROAD Woodstock, CT 06281 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-16 |
Decision Date | 2006-03-20 |
Summary: | summary |