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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
Applicant Contact SUBHASH PATEL
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747
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
Predetermined Change
Control Plan Authorized		 No
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