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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saw, Surgical, Ent (Electric Or Pneumatic)
510(k) Number K844765
Device Name ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
Applicant
LASER SPECTRUM, INC.
100 SOUTH WACKER DRIVE
CHICAGO,  IL  60606 -
Applicant Contact ROBERT E BROWNE
Correspondent
LASER SPECTRUM, INC.
100 SOUTH WACKER DRIVE
CHICAGO,  IL  60606 -
Correspondent Contact ROBERT E BROWNE
Regulation Number874.4420
Classification Product Code
EWQ  
Date Received12/07/1984
Decision Date 04/08/1985
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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