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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K884053
Device Name PRN PLUS + INFUSION SET
Applicant
PRN SERVICES, INC.
1210 MORSE
ROYAL OAK,  MI  48067
Applicant Contact FRED KAMIENNY
Correspondent
PRN SERVICES, INC.
1210 MORSE
ROYAL OAK,  MI  48067
Correspondent Contact FRED KAMIENNY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/26/1988
Decision Date 10/31/1988
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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