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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 K942189
Device Name CRYSTAL EAR
Applicant
Crystal Care Intl., Inc.
1919 Vandervort Rd.
Lutz,  FL  33549
Applicant Contact MICHAEL NEHR
Correspondent
Crystal Care Intl., Inc.
1919 Vandervort Rd.
Lutz,  FL  33549
Correspondent Contact MICHAEL NEHR
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/04/1994
Decision Date 08/09/1994
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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