OLYMPUS FG-45/46-1 GRASPING FORCEPS

Bronchoscope (flexible Or Rigid)

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.

Pre-market Notification Details

Device IDK962378
510k NumberK962378
Device Name:OLYMPUS FG-45/46-1 GRASPING FORCEPS
ClassificationBronchoscope (flexible Or Rigid)
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 CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-20
Decision Date1996-08-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170375061 K962378 000
14953170375054 K962378 000
14953170375047 K962378 000
14953170375030 K962378 000
14953170062350 K962378 000
14953170062282 K962378 000
14953170060592 K962378 000
14953170078931 K962378 000
14953170060561 K962378 000

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