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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound, Sinus
510(k) Number K960044
Device Name ULTRAMAX/MODEL NUMBER A1
Applicant
ENTLAB OY
5671 SANDIFORD PLACE
RICHMOND,  CA V7E 5M5
Applicant Contact MATTI REVONTA
Correspondent
ENTLAB OY
5671 SANDIFORD PLACE
RICHMOND,  CA V7E 5M5
Correspondent Contact MATTI REVONTA
Regulation Number892.1560
Classification Product Code
LWI  
Subsequent Product Code
ITX  
Date Received01/02/1996
Decision Date 08/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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