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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K952098
Device Name SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE
Applicant
Siemens Hearing Instruments, Inc.
10 Constitution Ave.
P.O. Box 1397
Piscataway,  NJ  08855
Applicant Contact GARY W ROESEL
Correspondent
Siemens Hearing Instruments, Inc.
10 Constitution Ave.
P.O. Box 1397
Piscataway,  NJ  08855
Correspondent Contact GARY W ROESEL
Regulation Number874.3310
Classification Product Code
ETW  
Date Received05/04/1995
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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