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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K844094
Device Name PRUITT IRRIGATION AND OCCLUSION CATHETER
Applicant
BIONOMY, INC.
P.O. BOX 270882
TAMPA,  FL  33688
Applicant Contact ELIZABETH M PAUL
Correspondent
BIONOMY, INC.
P.O. BOX 270882
TAMPA,  FL  33688
Correspondent Contact ELIZABETH M PAUL
Regulation Number878.4200
Classification Product Code
GBX  
Date Received10/18/1984
Decision Date 11/29/1984
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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