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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 K972135
Device Name MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
Applicant
P/L Biomedical
7690 Cameron Cir.
Fort Myers,  FL  33912
Correspondent
P/L Biomedical
7690 Cameron Cir.
Fort Myers,  FL  33912
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/06/1997
Decision Date 08/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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