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510(k) K964376

CIDE-SWIPES P-100B & CIDE-SWIPES C-100A by Mp Scientific, Inc. — Product Code LRJ

K964376 is an FDA 510(k) premarket notification submitted by Mp Scientific, Inc. for the device "CIDE-SWIPES P-100B & CIDE-SWIPES C-100A". The FDA issued a decision of Substantially Equivalent on December 23, 1996. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1996
Date Received
November 1, 1996
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 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