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510(k) K983065

MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM by Mentor Corp. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1998
Date Received
September 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)

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