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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dislodger, stone, basket, ureteral, metal
510(k) Number K930349
Device Name STONE RETRIEVAL BASKET
Applicant
ENDOMEDIX
2162 MICHELSON DR.
IRVINE,  CA  92715 -1304
Applicant Contact LEIGH WEINTRAUB
Correspondent
ENDOMEDIX
2162 MICHELSON DR.
IRVINE,  CA  92715 -1304
Correspondent Contact LEIGH WEINTRAUB
Regulation Number876.4680
Classification Product Code
FFL  
Date Received01/25/1993
Decision Date 06/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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