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510(k) K935063

INSTRU KLENZ by Calgon Corp. — Product Code FLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1994
Date Received
October 21, 1993
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

Other clearances by Calgon Corp.

  • K944950 — KLENZYME (December 20, 1994)
  • K943364 — CORASSIST WOUND DRESSING (August 3, 1994)
  • K940263 — NPH-KLENZ (May 18, 1994)
  • K940407 — KALTOGEL WOUND DRESSING (April 7, 1994)

Other clearances for product code FLG

  • K944950 — KLENZYME (December 20, 1994)
  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K940263 — NPH-KLENZ (May 18, 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)
  • K862282 — RAPIDEX BIOLOGICAL SURFACTANT (May 11, 1987)