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510(k) K933465

COSMET by Great Bay Medical Products, Inc. — Product Code KCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1994
Date Received
July 16, 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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