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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K873248
Device Name GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS
Applicant
Medical Engineering Laboratory, Inc.
108 W. Warren St., Suite 207
Shelby,  NC  28150
Applicant Contact WILLIAM J YOUNG
Correspondent
Medical Engineering Laboratory, Inc.
108 W. Warren St., Suite 207
Shelby,  NC  28150
Correspondent Contact WILLIAM J YOUNG
Regulation Number876.1500
Classification Product Code
OCZ  
Subsequent Product Code
FCL  
Date Received08/14/1987
Decision Date 12/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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