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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 K223116
Device Name 8X-10-6XXX Camera Head
Applicant
Santa Barbara Imaging Systems
340 Storke Road, Suite 101
Goleta,  CA  93117
Applicant Contact Jim Candy
Correspondent
Santa Barbara Imaging Systems
340 Storke Road, Suite 101
Goleta,  CA  93117
Correspondent Contact Jim Candy
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/03/2022
Decision Date 02/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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