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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K954984
Device Name MINIBORE STOPCOCK SET
Applicant
Distronic Sterile Products, Inc.
124 Heritage Ave.
Portsmouth,  NH  03801
Applicant Contact JOYCE MCDOUGALL
Correspondent
Distronic Sterile Products, Inc.
124 Heritage Ave.
Portsmouth,  NH  03801
Correspondent Contact JOYCE MCDOUGALL
Regulation Number880.5440
Classification Product Code
FMG  
Date Received10/31/1995
Decision Date 01/23/1996
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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