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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hearing aid, air-conduction, prescription
510(k) Number K972542
Device Name JAZZ PP AGC-O, JAZZ PP
Applicant
TRUTONE
3113 SOUTH 115TH EAST AVE.
TULSA,  OK  74146
Applicant Contact ZIAD SHWIYAT
Correspondent
TRUTONE
3113 SOUTH 115TH EAST AVE.
TULSA,  OK  74146
Correspondent Contact ZIAD SHWIYAT
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/09/1997
Decision Date 07/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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