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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 K983208
Device Name WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
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 Received09/14/1998
Decision Date 02/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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