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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 K955732
Device Name VENTED SOLUTION SET
Applicant
Distronic Sterile Products, Inc.
124 Heritage Ave.
Portsmouth,  NH  03801
Applicant Contact JOYCE MCDOUGAL
Correspondent
Distronic Sterile Products, Inc.
124 Heritage Ave.
Portsmouth,  NH  03801
Correspondent Contact JOYCE MCDOUGAL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/19/1995
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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