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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Amniotic Fluid (Amniocentesis Tray)
510(k) Number K922960
Device Name VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
Applicant
Cameo, Inc.
P.O. Box 525
Toledo,  OH  43693
Applicant Contact ROBERT FEDYNICH
Correspondent
Cameo, Inc.
P.O. Box 525
Toledo,  OH  43693
Correspondent Contact ROBERT FEDYNICH
Regulation Number884.1550
Classification Product Code
HIO  
Date Received06/18/1992
Decision Date 11/05/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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