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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 K801866
Device Name PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A
Applicant
Pentax Precision Instrument Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pentax Precision Instrument Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number874.4750
Classification Product Code
EQL  
Date Received08/05/1980
Decision Date 09/16/1980
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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