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510(k) K941163

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

K941163 is an FDA 510(k) premarket notification submitted by Calgon Vestal Div. for the device "MON-KLENZ". The FDA issued a decision of Substantially Equivalent on May 18, 1994. The device falls under product code FLG (Cleaner, Ultrasonic, Medical Instrument), a Class I device regulated under 21 CFR 880.6150. Calgon Vestal Div. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1994
Date Received
March 11, 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.

  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K942270 — SAF-GEL HYDRATING DERMAL WOUND DRESSING (August 4, 1994)
  • K931477 — AMERSE (June 17, 1994)
  • K931342 — LPH (May 26, 1994)
  • K931816 — VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM (May 26, 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)
  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 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)

FDA data resources