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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K983200
Device Name INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
Applicant
XIMED/PROSURE/INJECTX
2195 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
XIMED/PROSURE/INJECTX
2195 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number878.4800
Classification Product Code
GAA  
Subsequent Product Code
FHR  
Date Received09/14/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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