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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K960641
Device Name RECAP-1
Applicant
Medscience, Inc.
8803 Brecksville Rd., Suite 5
Brecksville,  OH  44141
Applicant Contact AUTUMN KLISKEY
Correspondent
Medscience, Inc.
8803 Brecksville Rd., Suite 5
Brecksville,  OH  44141
Correspondent Contact AUTUMN KLISKEY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/14/1996
Decision Date 05/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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