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510(k) K944950

KLENZYME by Calgon Corp. — Product Code FLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1994
Date Received
October 7, 1994
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.

  • K943364 — CORASSIST WOUND DRESSING (August 3, 1994)
  • K940263 — NPH-KLENZ (May 18, 1994)
  • K935063 — INSTRU KLENZ (May 9, 1994)
  • K940407 — KALTOGEL WOUND DRESSING (April 7, 1994)

Other clearances for product code FLG

  • 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)
  • 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)
  • K862282 — RAPIDEX BIOLOGICAL SURFACTANT (May 11, 1987)