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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 K921457
Device Name IRRIGATION PUMPS AND TUBING AND SUCTION TUBING
Applicant
American Surgical Instruments Corp.
430 Commerce Dr., Suite 50e
Delray Beach,  FL  33445
Applicant Contact DORSEY III
Correspondent
American Surgical Instruments Corp.
430 Commerce Dr., Suite 50e
Delray Beach,  FL  33445
Correspondent Contact DORSEY III
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/26/1992
Decision Date 05/13/1993
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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