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510(k) K904085

ELLA BREAST FORM by Coloplast A/S — Product Code KCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1990
Date Received
September 5, 1990
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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