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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Abortion Unit, Vacuum
510(k) Number K945179
Device Name BOTTLE COLLECTION SET
Applicant
Medgyn Products, Inc.
328 N. Eisenhower Ln.
Lombard,  IL  60148
Applicant Contact LAKSHMAN AGADI
Correspondent
Medgyn Products, Inc.
328 N. Eisenhower Ln.
Lombard,  IL  60148
Correspondent Contact LAKSHMAN AGADI
Regulation Number884.5070
Classification Product Code
HGF  
Date Received10/24/1994
Decision Date 01/26/1995
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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