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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 K873957
Device Name NON-CORING HUBER TYPE NEEDLES
Applicant
ADVANTAGE MEDICAL SYSTEMS, INC.
905 SHEEHY DR.
HORSHAM,  PA  19044
Applicant Contact JOEL A MARCUS
Correspondent
ADVANTAGE MEDICAL SYSTEMS, INC.
905 SHEEHY DR.
HORSHAM,  PA  19044
Correspondent Contact JOEL A MARCUS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/28/1987
Decision Date 10/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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