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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 K980082
Device Name J-TIP NEEDLESS INJECTOR
Applicant
National Medical Products, Inc.
57 Parker St.
Irvine,  CA  92718
Applicant Contact ROHIT PATEL
Correspondent
National Medical Products, Inc.
57 Parker St.
Irvine,  CA  92718
Correspondent Contact ROHIT PATEL
Regulation Number880.5430
Classification Product Code
KZE  
Date Received01/09/1998
Decision Date 03/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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