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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 K941659
Device Name AURAL-CAM, VIDEO EAR, VID RX
Applicant
Gracefully Yours, Inc.
12527 Ulmerton Rd.
Largo,  FL  34644
Applicant Contact RONALD A PRIEST
Correspondent
Gracefully Yours, Inc.
12527 Ulmerton Rd.
Largo,  FL  34644
Correspondent Contact RONALD A PRIEST
Regulation Number874.4770
Classification Product Code
ERA  
Date Received04/05/1994
Decision Date 04/26/1994
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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