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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 K955049
Device Name OLYMPUS FG-45/46-1 GRASPING FORCEPS
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact SUBHASH PATEL
Correspondent
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact SUBHASH PATEL
Regulation Number876.4680
Classification Product Code
FFL  
Date Received11/06/1995
Decision Date 12/15/1995
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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