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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K031882
Device Name ENDOSCOPIC APPLICATOR
Applicant
BAXTER HEALTHCARE CORP.
34175 ARDENWOOD BLVD.
FREMONT,  CA  94555
Applicant Contact LORI DONDIEGO
Correspondent
BAXTER HEALTHCARE CORP.
34175 ARDENWOOD BLVD.
FREMONT,  CA  94555
Correspondent Contact LORI DONDIEGO
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/18/2003
Decision Date 09/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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