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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, Metal
510(k) Number K851799
Device Name 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA
Applicant
Artiberia
4518 Los Ranchitos
San Antonio,  TX  78233
Applicant Contact GIL M SANCHEZ
Correspondent
Artiberia
4518 Los Ranchitos
San Antonio,  TX  78233
Correspondent Contact GIL M SANCHEZ
Regulation Number884.4520
Classification Product Code
HDF  
Date Received04/25/1985
Decision Date 05/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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