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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Punch, Biopsy, Surgical
510(k) Number K933670
Device Name BIOPSY PUNCH, SURGICAL
Applicant
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Applicant Contact BYRON G ECONOMIDY, JR.
Correspondent
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Correspondent Contact BYRON G ECONOMIDY, JR.
Regulation Number872.4565
Classification Product Code
EME  
Date Received07/28/1993
Decision Date 01/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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