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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 K921208
Device Name ACCU-BEAM TUBE SET
Applicant
TTI MEDICAL
7026 KOLL CENTER PKWY.
SUITE 207
PLEASANTON,  CA  94566
Applicant Contact LOWELL CROW
Correspondent
TTI MEDICAL
7026 KOLL CENTER PKWY.
SUITE 207
PLEASANTON,  CA  94566
Correspondent Contact LOWELL CROW
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/12/1992
Decision Date 06/01/1993
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
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