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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 K904107
Device Name CAP-AID
Applicant
Nda Systems
6229 S. Iola Way
Englewood,  CO  80111
Applicant Contact STEVEN B ARAGON
Correspondent
Nda Systems
6229 S. Iola Way
Englewood,  CO  80111
Correspondent Contact STEVEN B ARAGON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/06/1990
Decision Date 12/14/1990
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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