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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Breast, External, Used With Adhesive
510(k) Number K932978
Device Name CALSSIQUE OR MYSTIQUE
Applicant
Dekumed, Kunststofftechnik Degler GmbH
Am Anger 27
8214 Bernau
Germany,  DE
Applicant Contact PETER RICKAUER
Correspondent
Dekumed, Kunststofftechnik Degler GmbH
Am Anger 27
8214 Bernau
Germany,  DE
Correspondent Contact PETER RICKAUER
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received06/17/1993
Decision Date 12/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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