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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Balloon Type
510(k) Number K861877
Device Name BYRON WORD BARTHOLIAN GLAND CATHETER
Applicant
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Applicant Contact FRED CHAPEL
Correspondent
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Correspondent Contact FRED CHAPEL
Regulation Number878.4200
Classification Product Code
GBA  
Date Received05/15/1986
Decision Date 05/30/1986
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
Predetermined Change
Control Plan Authorized		 No
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