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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 K950983
Device Name IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE
Applicant
Introspect, Inc.
5641 Zumbra Dr.
Excelsior,  MN  55331
Applicant Contact RICHARD C HAWLEY
Correspondent
Introspect, Inc.
5641 Zumbra Dr.
Excelsior,  MN  55331
Correspondent Contact RICHARD C HAWLEY
Regulation Number874.4770
Classification Product Code
ERA  
Date Received03/03/1995
Decision Date 04/12/1995
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
Predetermined Change
Control Plan Authorized		 No
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