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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 6-412
Standard
USP 41-NF36:2018
Sodium Chloride Irrigation
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§880.6740 Catheter And Tip, Suction Class 2 JOL
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Ramesh K. Panguluri
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6303
  ramesh.panguluri@fda.hhs.gov
Standards Development Organization
USP United States Pharmacopeial Convention, Inc. http://www.usp.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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