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510(k) K944494

ALSA-KLENZ by Calgon Vestal Div. — Product Code FLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1994
Date Received
September 13, 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 Vestal Div.

  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K942270 — SAF-GEL HYDRATING DERMAL WOUND DRESSING (August 4, 1994)
  • K931477 — AMERSE (June 17, 1994)
  • K931816 — VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM (May 26, 1994)
  • K931342 — LPH (May 26, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K931573 — VESPHENE II (May 16, 1994)
  • K932277 — LONZA FORMULATION R-82 (May 12, 1994)
  • K931599 — HYDRASORB STERILE DRESSING (July 8, 1993)
  • K926034 — EPI-LOCK WOUND DRESSING (April 20, 1993)

Other clearances for product code FLG

  • K944950 — KLENZYME (December 20, 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)