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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K905463
Device Name GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION
Applicant
Angiosystems, Inc.
C/O Medical Device Inspeciton
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
Angiosystems, Inc.
C/O Medical Device Inspeciton
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/05/1990
Decision Date 01/22/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
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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