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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K992736
Device Name WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
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 Number884.4530
Classification Product Code
HIB  
Date Received08/13/1999
Decision Date 09/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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