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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 030 Publication Date: 01/15/2013 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 6-284: USP 35-NF30:2012, Sodium Chloride Injection. (General Plastic Surgery/General Hospital)

Date of Standard: 2012. 
Address of Standards Organization:
  United States Pharmacopeial Convention, Inc. (USP)
  12601 Twinbrook Parkway
  Rockville, MD 20852
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
IV catheter, piston syringe, single lumen hypodermic needle, lock flush solutions
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§880.5200 Saline, Vascular Access Flush Class 2 NGT
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  Ramesh K. Panguluri, Ph.D
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2506
  Silver Spring MD 20993
  301/796-6303
  Email: ramesh.panguluri@fda.hhs.gov
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