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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K871873
Device Name CLOSED CHEST DRAINAGE SET
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 Number878.4370
Classification Product Code
LRO  
Date Received05/13/1987
Decision Date 07/09/1987
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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