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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumoperitoneum Needle
510(k) Number K010779
Device Name MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
Applicant
Gibbons Surgical Corp.
1112 Jensen Dr., Suite 101
Virginia Beach,  VA  23451
Applicant Contact LISA CRISSON
Correspondent
Gibbons Surgical Corp.
1112 Jensen Dr., Suite 101
Virginia Beach,  VA  23451
Correspondent Contact LISA CRISSON
Regulation Number876.1500
Classification Product Code
FHO  
Date Received03/15/2001
Decision Date 04/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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