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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 6-269: ASTM F1078-10 (Reapproved 2011), standard terminology for surgical scissors-inserted and non-inserted blades. (General Plastic Surgery/General Hospital)

Date of Standard: 2010. 
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)
(3)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
Devices Affected:
Surgical Scissors
Processes Affected:
Premarket Notification, GMP, Design Controls and MDR Review
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.4565 Scissors, Surgical Tissue, Dental Class 1 EGN
§878.4800 Scissors, General, Surgical Class 1 LRW
§880.6820 Scissors, Medical, Disposable Class 1 JOK
§888.4540 Scissors, Orthopedic, Surgical Class 1 HRR
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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