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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K862624
Device Name I81 CITE
Applicant
OTICON CORP.
29 SCHOOLHOUSE RD.
P.O. BOX 6724
SOMERSET,  NJ  08873
Applicant Contact HENNING V FALSTER
Correspondent
OTICON CORP.
29 SCHOOLHOUSE RD.
P.O. BOX 6724
SOMERSET,  NJ  08873
Correspondent Contact HENNING V FALSTER
Regulation Number874.4770
Classification Product Code
ERA  
Date Received07/10/1986
Decision Date 08/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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