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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, electrosurgical
510(k) Number K833648
Device Name OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S
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 Number878.4400
Classification Product Code
HAM  
Date Received10/17/1983
Decision Date 11/29/1983
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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