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510(k) K060458

MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR by Langford IC Systems, Inc. — Product Code FEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2006
Date Received
February 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Cleaning, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Langford IC Systems, Inc.

  • K101158 — LIC INSTRUMENT PROCESSING SYSTEM (May 6, 2011)
  • K043314 — MANZI CLEANER SYSTEM (June 20, 2005)

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