SYSTEMS INTEGRATION

Endoscopic Central Control Unit

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Systems Integration.

Pre-market Notification Details

Device IDK102763
510k NumberK102763
Device Name:SYSTEMS INTEGRATION
ClassificationEndoscopic Central Control Unit
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
ContactStacy Abbatiello
CorrespondentStacy Abbatiello
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
Product CodeODA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-24
Decision Date2011-02-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170291579 K102763 000
04953170291555 K102763 000
04953170291531 K102763 000

Trademark Results [SYSTEMS INTEGRATION]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYSTEMS INTEGRATION
SYSTEMS INTEGRATION
73798618 1597966 Dead/Cancelled
REED PUBLISHING (USA) INC.
1989-05-08

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