ALLEN, ULTRA AND SMART SOCKETS

Table, Operating-room, Ac-powered

ALLEN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Allen Medical Systems, Inc. with the FDA for Allen, Ultra And Smart Sockets.

Pre-market Notification Details

Device IDK971988
510k NumberK971988
Device Name:ALLEN, ULTRA AND SMART SOCKETS
ClassificationTable, Operating-room, Ac-powered
Applicant ALLEN MEDICAL SYSTEMS, INC. 15627 NEO PKWY. Cleveland,  OH  44128
ContactSuzanne Kay Ratzloff
CorrespondentSuzanne Kay Ratzloff
ALLEN MEDICAL SYSTEMS, INC. 15627 NEO PKWY. Cleveland,  OH  44128
Product CodeFQO  
Subsequent Product CodeFWW
Subsequent Product CodeGDC
CFR Regulation Number878.4960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-29
Decision Date1997-07-11

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