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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K972655
Device Name CONTROL SYRINGE
Applicant
Medical Specialties Intl., Inc.
615 Jasmine Ave. N.
Tarpon Springs,  FL  34689
Applicant Contact LARRY G JUNKER
Correspondent
Medical Specialties Intl., Inc.
615 Jasmine Ave. N.
Tarpon Springs,  FL  34689
Correspondent Contact LARRY G JUNKER
Regulation Number892.1600
Classification Product Code
IZI  
Date Received07/15/1997
Decision Date 11/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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