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510(k) K010709

MENTOR STERILE SALINE MAMMARY VOLUME SIZERS by Mentor Corp. — Product Code MRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2001
Date Received
March 9, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mammary Sizer
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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  • K011500 — MENTOR CONTOUR PROFILE TISSUE EXPANDER (December 3, 2001)
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  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)

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  • K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZER (February 12, 1999)
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