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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K053510
Device Name IR WIRELESS FOOT SWITCH
Applicant
LINEMASTER SWITCH CORP.
29 PLAINE HILL ROAD
WOODSTOCK,  CT  06281
Applicant Contact MIKE SZOSTEK
Correspondent
LINEMASTER SWITCH CORP.
29 PLAINE HILL ROAD
WOODSTOCK,  CT  06281
Correspondent Contact MIKE SZOSTEK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/16/2005
Decision Date 03/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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