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510(k) K880814

DX101 ULTRASONIC SURGICAL SYSTEM by Niic U.S.A., Inc. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1988
Date Received
February 17, 1988
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 Niic U.S.A., Inc.

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  • K901204 — EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS (June 5, 1990)
  • K900185 — NIIC MODEL: DX901 ASPIRATION SYSTEM (May 24, 1990)
  • K896988 — NIIC LASER SYSTEM (January 23, 1990)
  • K895581 — MODEL: IR205 ARTICULATED SURGICAL LASER (December 13, 1989)
  • K895247 — MODEL IR103 SURGICAL LASER SYSTEM (November 16, 1989)
  • K892359 — MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM (November 16, 1989)
  • K895239 — MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER (November 16, 1989)

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