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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 K925805
Device Name KENDALL WOUND DRAINAGE SYSTEMS-TROCARS
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact JOHN J VOZELLA
Correspondent
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact JOHN J VOZELLA
Regulation Number878.4200
Classification Product Code
GBX  
Date Received11/16/1992
Decision Date 02/26/1993
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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