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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 K873377
Device Name CLOSED CHEST DRAINAGE SET W/SUTURES
Applicant
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Applicant Contact JEANNE PIERSON
Correspondent
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Correspondent Contact JEANNE PIERSON
Regulation Number878.4200
Classification Product Code
GBS  
Date Received08/24/1987
Decision Date 10/28/1987
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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