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510(k) K932978

CALSSIQUE OR MYSTIQUE by Dekumed, Kunststofftechnik Degler GmbH — Product Code KCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1993
Date Received
June 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Breast, External, Used With Adhesive
Device Class
Class I
Regulation Number
878.3800
Review Panel
SU
Submission Type

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