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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K991562
Device Name PASCAL MEDICAL AB MENIETT 20
Applicant
Pascal Medical AB
7307 Glouchester Dr.
Minneapolis,  MN  55435
Applicant Contact JEFFREY R SIDEMAN
Correspondent
Pascal Medical AB
7307 Glouchester Dr.
Minneapolis,  MN  55435
Correspondent Contact JEFFREY R SIDEMAN
Regulation Number874.1090
Classification Product Code
ETY  
Date Received05/04/1999
Decision Date 12/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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