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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aspirator, endometrial
510(k) Number K902693
Device Name WALLACH FLEXIBLE ENDOMETRIAL SAMPLER
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 Number884.1060
Classification Product Code
HFF  
Date Received06/19/1990
Decision Date 01/31/1991
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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