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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 K860157
Device Name NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET
Applicant
Quest Medical, Inc.
3312 Wiley Post Rd.
Carrollton,  TX  75006
Applicant Contact CLAUDE PERING
Correspondent
Quest Medical, Inc.
3312 Wiley Post Rd.
Carrollton,  TX  75006
Correspondent Contact CLAUDE PERING
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/16/1986
Decision Date 04/09/1986
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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