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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K923304
Device Name FAMILY EAR SCOPE MODEL 29001S
Applicant
Ear Care of So. Ca., Inc.
3 Westwick Ct.
Annapolis,  MD  21403
Applicant Contact PLAVNER
Correspondent
Ear Care of So. Ca., Inc.
3 Westwick Ct.
Annapolis,  MD  21403
Correspondent Contact PLAVNER
Regulation Number874.4770
Classification Product Code
ERA  
Date Received07/06/1992
Decision Date 10/21/1992
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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