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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name holder, ear speculum
510(k) Number K822011
Device Name SHEA'S EAR SPECULUM HOLDER PORT MANNS
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 Number878.1800
Classification Product Code
JYK  
Date Received07/08/1982
Decision Date 08/12/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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