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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hook, Microsurgical Ear
510(k) Number K772390
Device Name DAY EAR HOOK
Applicant
EDWARD WECK, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EDWARD WECK, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4420
Classification Product Code
JYL  
Date Received12/27/1977
Decision Date 01/17/1978
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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