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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K921791
Device Name WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
Applicant
WALLACH SURGICAL DEVICES, INC.
291 PEPE'S FARM RD.
MILFORD,  CT  06460
Applicant Contact VINCENT FRAZZETTA
Correspondent
WALLACH SURGICAL DEVICES, INC.
291 PEPE'S FARM RD.
MILFORD,  CT  06460
Correspondent Contact VINCENT FRAZZETTA
Regulation Number884.4120
Classification Product Code
HGI  
Date Received04/14/1992
Decision Date 05/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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