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510(k) K931573

VESPHENE II by Calgon Vestal Div. — Product Code LRJ

K931573 is an FDA 510(k) premarket notification submitted by Calgon Vestal Div. for the device "VESPHENE II". The FDA issued a decision of Substantially Equivalent on May 16, 1994. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Calgon Vestal Div. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1994
Date Received
March 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfectant, Medical Devices
Device Class
Class I
Regulation Number
880.6890
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)
  • K941163 — MON-KLENZ (May 18, 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 LRJ

  • K992661 — CONTROL III ELITE (September 14, 1999)
  • K991509 — PRO-PORTION CLEANER/DISINFECTANT (July 14, 1999)
  • K984485 — MICROSTAT 2 (January 13, 1999)
  • K983947 — AMERSE 2 (December 4, 1998)
  • K983869 — DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH (November 30, 1998)
  • K983585 — LOW PH PHENOLIC 256 (November 6, 1998)
  • K982985 — CITREX HOSPITAL SPRAY DISINFECTANT (November 2, 1998)
  • K981023 — KLEENASEPTIC (April 30, 1998)
  • K980369 — T.B.Q. RTU (February 17, 1998)
  • K974304 — GERMICIDAL CLOTH (January 13, 1998)

FDA data resources