OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)

Dislodger, Stone, Basket, Ureteral, Metal

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Fg-45/46-1 Grasping Forceps(urology).

Pre-market Notification Details

Device IDK962387
510k NumberK962387
Device Name:OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
ClassificationDislodger, Stone, Basket, Ureteral, Metal
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactBarry E Sands
CorrespondentBarry E Sands
OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeFFL  
CFR Regulation Number876.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-20
Decision Date1996-07-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170031721 K962387 000
14953170031707 K962387 000
14953170031677 K962387 000
14953170031653 K962387 000

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