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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngostroboscope
510(k) Number K842090
Device Name RHINO-LARYNX STROBOSCOPE TYPE 4914
Applicant
BRUEL & KJAER INDUSTRI A/S
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BRUEL & KJAER INDUSTRI A/S
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4750
Classification Product Code
EQL  
Date Received05/24/1984
Decision Date 07/18/1984
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
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