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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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