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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 6-271: ASTM F1874-98 9Reapproved 2011), standard test method for bend testing of needles used in surgical sutures. (General Plastic Surgery/General Hospital)

Date of Standard: 1998. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Surgical Suture Needle
Processes Affected:
Premarket Notification, Design Controls
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§878.4800 Needle, Suturing, Disposable Class 1 GAB
§878.4800 Needle, Suturing, Reusable Class 1 GDL
§882.4650 Needle, Neurosurgical Suture Class 1 HAS
FDA Technical Contact:
 Long Chen, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1461
  Silver Spring MD 20993
  301/796-6389
  email: long.chen@fda.hhs.gov
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