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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colposcope (And Colpomicroscope)
510(k) Number K001314
Device Name MEDSCOPE
Applicant
ALL-PRO IMAGING CORP.
70 CANTIAGUE ROCK RD.
P.O. BOX 870
HICKSVILLE,  NY  11801
Applicant Contact JOSEPH CAREY
Correspondent
ALL-PRO IMAGING CORP.
70 CANTIAGUE ROCK RD.
P.O. BOX 870
HICKSVILLE,  NY  11801
Correspondent Contact JOSEPH CAREY
Regulation Number884.1630
Classification Product Code
HEX  
Date Received04/26/2000
Decision Date 07/25/2000
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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