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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K933757
Device Name HAND-HELD IRRIGATION PUMP
Applicant
XIMED MEDICAL SYSTEMS
2195 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
XIMED MEDICAL SYSTEMS
2195 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number878.4780
Classification Product Code
BTA  
Date Received07/14/1993
Decision Date 08/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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