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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 K880195
Device Name GYNESCOPE
Applicant
Medgyn Products, Inc.
2808 A. Center Cir.
Downers Grove,  IL  60515
Applicant Contact LAKSHMAN AGADI
Correspondent
Medgyn Products, Inc.
2808 A. Center Cir.
Downers Grove,  IL  60515
Correspondent Contact LAKSHMAN AGADI
Regulation Number884.1630
Classification Product Code
HEX  
Date Received01/26/1988
Decision Date 03/14/1988
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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