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510(k) K935063

INSTRU KLENZ by Calgon Corp. — Product Code FLG

K935063 is an FDA 510(k) premarket notification submitted by Calgon Corp. for the device "INSTRU KLENZ". The FDA issued a decision of Substantially Equivalent on May 9, 1994. The device falls under product code FLG (Cleaner, Ultrasonic, Medical Instrument), a Class I device regulated under 21 CFR 880.6150. Calgon Corp. has at least 4 other 510(k) clearances on record.

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)
  • K940263 — NPH-KLENZ (May 18, 1994)
  • K941163 — MON-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)

FDA data resources