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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, injection
510(k) Number K822201
Device Name EAR CANNULAS
Applicant
KELLEHER CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KELLEHER CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4200
Classification Product Code
FGY  
Date Received07/23/1982
Decision Date 10/06/1982
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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