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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K965208
Device Name POLYFIN EXTENSION SET, MODELS 126 AND 128
Applicant
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Applicant Contact TERRANCE H GREGG
Correspondent
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Correspondent Contact TERRANCE H GREGG
Regulation Number880.5440
Classification Product Code
FPK  
Date Received12/27/1996
Decision Date 02/26/1997
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
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