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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 K930463
Device Name LOCKING PIVOTAL THORACOPORT
Applicant
Surgical Technologies, Inc.
4715 NW 157th St., Suite 212
Miami Lakes,  FL  33014
Applicant Contact LASZLO FAZEKAS
Correspondent
Surgical Technologies, Inc.
4715 NW 157th St., Suite 212
Miami Lakes,  FL  33014
Correspondent Contact LASZLO FAZEKAS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/28/1993
Decision Date 09/07/1993
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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