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510(k) K991562

PASCAL MEDICAL AB MENIETT 20 by Pascal Medical AB — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1999
Date Received
May 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type

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