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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Face Plate Hearing Aid
510(k) Number K896304
Device Name OLYMPIA FACEPLATE MODULE
Applicant
Olympia Instruments, Inc.
1499 S. Hwy. 17-92
Longwood,  FL  32750
Applicant Contact PHILLIP RECHISTER
Correspondent
Olympia Instruments, Inc.
1499 S. Hwy. 17-92
Longwood,  FL  32750
Correspondent Contact PHILLIP RECHISTER
Regulation Number874.3300
Classification Product Code
LRB  
Date Received10/30/1989
Decision Date 01/26/1990
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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