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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 K884212
Device Name WINGED NON-CORING NEEDLE SET
Applicant
Marquette Medical, Inc.
2134 Espey Ct. #7
Crofton,  MD  21114
Applicant Contact EARL D MARQUETTE,JR
Correspondent
Marquette Medical, Inc.
2134 Espey Ct. #7
Crofton,  MD  21114
Correspondent Contact EARL D MARQUETTE,JR
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/06/1988
Decision Date 10/17/1988
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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