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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elevator, Ent
510(k) Number K772391
Device Name BOIES NASAL FRACTURE ELEVATOR
Applicant
EDWARD WECK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EDWARD WECK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4420
Classification Product Code
KAD  
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
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