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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, sinus
510(k) Number K942495
Device Name SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
Applicant
ATOS MEDICAL AB
P.O. BOX 183
HORBY, SWEDEN,  SE SE-24222
Correspondent
ATOS MEDICAL AB
P.O. BOX 183
HORBY, SWEDEN,  SE SE-24222
Regulation Number878.4800
Classification Product Code
KAM  
Date Received05/17/1994
Decision Date 02/21/1995
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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