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510(k) K983585

LOW PH PHENOLIC 256 by Central Solutions, Inc. — Product Code LRJ

K983585 is an FDA 510(k) premarket notification submitted by Central Solutions, Inc. for the device "LOW PH PHENOLIC 256". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Central Solutions, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1998
Date Received
October 13, 1998
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 Central Solutions, Inc.

  • K955850 — PRO-TECH (February 9, 1996)
  • K954292 — Q5. 5-5.5NPB-2.5HW (September 27, 1995)
  • K951020 — TRI-CEN GERMICIDAL DETERGENT (August 28, 1995)
  • K951162 — PHENO-CEN GERMICIDAL DETERGENT (July 11, 1995)
  • K951342 — Q4.5-5.0PB-4.5 (April 25, 1995)
  • K951317 — PHENO-CEN SPRAY DISINFECTANT DEODORANT (April 25, 1995)

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)
  • 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)
  • K961044 — NOVIGUARD QUICK DRY (July 3, 1997)

FDA data resources