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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 K913999
Device Name NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE
Applicant
American Surgical Instruments Corp.
901 E. Sample Rd., Suite C
Pompano Beach,  FL  33064
Applicant Contact JAMES H DORSEY
Correspondent
American Surgical Instruments Corp.
901 E. Sample Rd., Suite C
Pompano Beach,  FL  33064
Correspondent Contact JAMES H DORSEY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/06/1991
Decision Date 11/01/1991
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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