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510(k) K971580

UAS ULTRASONIC ASPIRATOR SYSTEM by Wells Johnson Co. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1997
Date Received
April 30, 1997
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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  • K945500 — WELLS JOHNSON FIXATION SYSTEM (September 21, 1995)
  • K951519 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (June 14, 1995)
  • K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (March 2, 1995)
  • K945805 — WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE (December 13, 1994)
  • K854068 — EXTERNAL MECHANICAL FASTENER (November 22, 1985)
  • K843188 — WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP (September 20, 1984)
  • K832520 — SUCTION TIPS (October 20, 1983)

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