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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 K934534
Device Name TROCAR W/CANNULA, O RING, ADAPTER, AND ADAPTER SLEEVE MODIFICATION
Applicant
Baxter Healthcare Corp
1435 Lake Cook Rd.
Deerfield,  IL  60015
Applicant Contact NICOLE M CLARK
Correspondent
Baxter Healthcare Corp
1435 Lake Cook Rd.
Deerfield,  IL  60015
Correspondent Contact NICOLE M CLARK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/17/1993
Decision Date 12/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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