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510(k) K151101

Lotus Series 4 Ultrasonic Surgical System & Accessories by Sra Developments, Ltd. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2015
Date Received
April 24, 2015
Clearance Type
Special
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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  • K063531 — SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM (February 22, 2007)
  • K032424 — LOTUS (December 16, 2003)

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