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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 K904198
Device Name SAFETY NEEDLE SHEATH
Applicant
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/12/1990
Decision Date 12/19/1990
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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