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510(k) K063531

SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM by Sra Developments, Ltd. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2007
Date Received
November 22, 2006
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

Other clearances by Sra Developments, Ltd.

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  • K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (December 19, 2007)
  • K032424 — LOTUS (December 16, 2003)

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