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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 K020711
Device Name WALLACH LOOP ELECTRODE
Applicant
WALLACH SURGICAL DEVICES, INC.
235 EDISON RD.
ORANGE,  CT  06477
Applicant Contact MICHAEL MALIS
Correspondent
WALLACH SURGICAL DEVICES, INC.
235 EDISON RD.
ORANGE,  CT  06477
Correspondent Contact MICHAEL MALIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/05/2002
Decision Date 06/03/2002
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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