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510(k) K032424

LOTUS by Sra Developments, Ltd. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2003
Date Received
August 5, 2003
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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  • K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (December 19, 2007)
  • K063531 — SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM (February 22, 2007)

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