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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Inflation, Middle Ear
510(k) Number K920840
Device Name OTOVENT
Applicant
ABIGO MEDICAL AB
DATAVAGEN 23, S-436 32 ASKIM
S-436 32 ASKIM
SWEDEN,  SE
Applicant Contact JAN G SMITH
Correspondent
ABIGO MEDICAL AB
DATAVAGEN 23, S-436 32 ASKIM
S-436 32 ASKIM
SWEDEN,  SE
Correspondent Contact JAN G SMITH
Classification Product Code
MJV  
Date Received02/24/1992
Decision Date 10/05/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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