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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 K945297
Device Name INFRA VISION IMAGING SYSTEM
Applicant
Gabriel Medical, Inc.
2014 W. Pinhook Rd., #604
Lafayette,  LA  70508
Applicant Contact MARY M MCNAMARA
Correspondent
Gabriel Medical, Inc.
2014 W. Pinhook Rd., #604
Lafayette,  LA  70508
Correspondent Contact MARY M MCNAMARA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/31/1994
Decision Date 12/20/1994
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
Recalls CDRH Recalls
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