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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 CIRCLE
FORT MYERS,  FL  33912
Correspondent
P/L Biomedical
7690 CAMERON CIRCLE
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
Recalls CDRH Recalls
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