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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K822259
Device Name LARYNGEAL SPATULAS
Applicant
KELLEHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KELLEHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4350
Classification Product Code
EQH  
Date Received07/29/1982
Decision Date 10/22/1982
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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