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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, ventricular, general & plastic surgery
510(k) Number K863142
Device Name THORACIC CATHETER (CHEST DRAINAGE TUBE)
Applicant
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Applicant Contact JOHN STEEN
Correspondent
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Correspondent Contact JOHN STEEN
Regulation Number878.4200
Classification Product Code
GBS  
Date Received08/15/1986
Decision Date 08/29/1986
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
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