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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 K913365
Device Name ACCUSCOPE(TM) & ACCUSCOPE II(TM)
Applicant
Vineland Medical Products, Inc.
P.O. Box 575
1471 E. Chestnut Ave.
Vineland,  NJ  08360
Applicant Contact DON PASQUALE
Correspondent
Vineland Medical Products, Inc.
P.O. Box 575
1471 E. Chestnut Ave.
Vineland,  NJ  08360
Correspondent Contact DON PASQUALE
Regulation Number884.1630
Classification Product Code
HEX  
Date Received07/29/1991
Decision Date 04/27/1992
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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