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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Larynx, Artificial (Battery-Powered)
510(k) Number K923648
Device Name LECTRO-LARYNX
Applicant
Bruce Medical Supply
411 Waverly Oaks Rd.
Waltham,  MA  02154
Applicant Contact RICHARD A NAJARIAN
Correspondent
Bruce Medical Supply
411 Waverly Oaks Rd.
Waltham,  MA  02154
Correspondent Contact RICHARD A NAJARIAN
Regulation Number874.3375
Classification Product Code
ESE  
Date Received07/21/1992
Decision Date 04/07/1993
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
Predetermined Change
Control Plan Authorized		 No
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