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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 K930499
Device Name GRASPING FORCEPS FLEXIBLE STONE DISLODGER
Applicant
Endomedix
2162 Michelson Dr.
Irvine,  CA  92715
Applicant Contact LEIGH WEINTRAUB
Correspondent
Endomedix
2162 Michelson Dr.
Irvine,  CA  92715
Correspondent Contact LEIGH WEINTRAUB
Regulation Number876.1500
Classification Product Code
OCZ  
Date Received02/01/1993
Decision Date 08/16/1993
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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