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510(k) K842754

CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 by Custom Ultrasonics — Product Code FLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1984
Date Received
July 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Ultrasonic, Medical Instrument
Device Class
Class I
Regulation Number
880.6150
Review Panel
HO
Submission Type

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  • K061430 — SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR (January 12, 2007)
  • K983017 — MODIFICATION TO SYSTEM 83 PLUS (September 22, 1998)

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  • K940263 — NPH-KLENZ (May 18, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K935063 — INSTRU KLENZ (May 9, 1994)
  • K934666 — PDS ULTRACLEAN (April 15, 1994)
  • K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (April 13, 1994)
  • K933149 — INSTRUMENT DETERGENT CONCENTRATE (February 16, 1994)
  • K884660 — BIOSONIC ULTRASONIC CLEANING SYSTEM (March 16, 1989)