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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K800617
Device Name HYFRECATOR, #733
Applicant
BIRTCHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIRTCHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/18/1980
Decision Date 05/02/1980
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
Recalls CDRH Recalls
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