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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: SUPPLEMENTARY INFORMATION

ANSI , . ()
Address of Standards Organization:
  American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Offices and Divisions Associated with Recognized Standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Processes Affected:
Type of Standard:
 National, Vertical
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§874.3300 Hearing Aid, Air Conduction Class 1 ESD
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§874.3310 Calibrator, Hearing Aid / Earphone And Analysis Systems Class 2 ETW
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§874.3320 Hearing Aid, Group And Auditory Trainer Class 2 EPF
 
FDA Technical Contact:
  Teresa Cygnarowicz
  FDA/CDRH/ODE
  9200 CORPORATE BLVD, HFZ-460
  ROCKVILLE MD 20850
  240/276-4247
  Email: teresa.cygnarowicz@fda.hhs.gov
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