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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 K860242
Device Name JMS INFUSION SET
Applicant
STURBRIDGE MEDICAL
SUITE K
2081 BERING DRIVE
SAN JOSE,  CA  95131
Applicant Contact HARRY GARDNER
Correspondent
STURBRIDGE MEDICAL
SUITE K
2081 BERING DRIVE
SAN JOSE,  CA  95131
Correspondent Contact HARRY GARDNER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/24/1986
Decision Date 02/13/1986
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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