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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 K955709
Device Name WINGED & SUBCUTANEOUS INFUSION SETS
Applicant
Distronic Sterile Products, Inc.
124 Heritage Ave.
Portsmouth,  NH  03801 -5645
Applicant Contact JOYCE MCDOUGALL
Correspondent
Distronic Sterile Products, Inc.
124 Heritage Ave.
Portsmouth,  NH  03801 -5645
Correspondent Contact JOYCE MCDOUGALL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/18/1995
Decision Date 02/21/1996
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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