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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 K071756
Device Name ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE
Applicant
Pointe Conception Medical, Inc.
121 E. Mason St.
Santa Barbara,  CA  93101
Applicant Contact WILLIAM C HAACK
Correspondent
Pointe Conception Medical, Inc.
121 E. Mason St.
Santa Barbara,  CA  93101
Correspondent Contact WILLIAM C HAACK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/28/2007
Decision Date 08/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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