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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K850754
Device Name MEDAJET XL - JET INJECTOR
Applicant
Mada Medical Products, Inc.
60 Commerce Rd.
Carlstadt,  NJ  07072
Applicant Contact ADAM
Correspondent
Mada Medical Products, Inc.
60 Commerce Rd.
Carlstadt,  NJ  07072
Correspondent Contact ADAM
Regulation Number880.5430
Classification Product Code
KZE  
Date Received02/25/1985
Decision Date 12/10/1985
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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