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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K090830
Device Name LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
Applicant
Laborie Medical Technologies, Ltd.
400 Ave. D
Suite 10
Williston,  VT  05495
Applicant Contact BARBARA MORNET
Correspondent
Laborie Medical Technologies, Ltd.
400 Ave. D
Suite 10
Williston,  VT  05495
Correspondent Contact BARBARA MORNET
Regulation Number876.1500
Classification Product Code
FBK  
Date Received03/26/2009
Decision Date 07/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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