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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K895831
Device Name NEEDLEPOINT GUARD
Applicant
Needlepoint Guard, Inc.
P.O. Box 1646
Grand Island,  NE  68802
Applicant Contact HAKE, MD
Correspondent
Needlepoint Guard, Inc.
P.O. Box 1646
Grand Island,  NE  68802
Correspondent Contact HAKE, MD
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/02/1989
Decision Date 12/01/1989
Decision Substantially Equivalent (SESE)
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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