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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K922962
Device Name VARIOUS CAMEO MED BASIC BIOPSY 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 Number878.4370
Classification Product Code
KKX  
Date Received06/18/1992
Decision Date 03/23/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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