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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 K926150
Device Name VINYL ADDITION SILICONE SYSTEM
Applicant
CROWN DELTA CORP.
1550 FRONT ST.
YORKTOWN HEIGHTS,  NY  10598
Applicant Contact LAURENCE COLIN
Correspondent
CROWN DELTA CORP.
1550 FRONT ST.
YORKTOWN HEIGHTS,  NY  10598
Correspondent Contact LAURENCE COLIN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/07/1992
Decision Date 07/14/1993
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
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