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510(k) K991509

PRO-PORTION CLEANER/DISINFECTANT by Sultan Chemists, Inc. — Product Code LRJ

K991509 is an FDA 510(k) premarket notification submitted by Sultan Chemists, Inc. for the device "PRO-PORTION CLEANER/DISINFECTANT". The FDA issued a decision of Substantially Equivalent on July 14, 1999. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Sultan Chemists, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1999
Date Received
April 30, 1999
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 Sultan Chemists, Inc.

  • K052699 — VERSA-LINK PORCELAIN BONDING SYSTEM (November 16, 2005)
  • K052409 — SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL (October 20, 2005)
  • K043054 — GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL (February 18, 2005)
  • K030414 — GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL (April 9, 2003)
  • K020612 — SULTAN SPOROX TEST VIAL, MODEL 75195 (May 7, 2002)
  • K002843 — SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 (November 15, 2000)
  • K971138 — DINABASE (TM) (July 21, 1997)
  • K951590 — ASSURE, SELF-SEALING STERILIZATION POUCH (May 17, 1995)
  • K933729 — ASSURE SELF SEALING STERILIZATION POUCH (June 21, 1994)
  • K896826 — SULTAN PERIO-SELECT IRRIGATION SYSTEM (March 2, 1990)

Other clearances for product code LRJ

  • K992661 — CONTROL III ELITE (September 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)
  • K961044 — NOVIGUARD QUICK DRY (July 3, 1997)

FDA data resources