COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM

Apparatus, Suction, Operating-room, Wall Vacuum Powered

COOPERSURGICAL, INC.

The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Coopersurgical Model 6080 Smoke Evacuator System.

Pre-market Notification Details

Device IDK910377
510k NumberK910377
Device Name:COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
ClassificationApparatus, Suction, Operating-room, Wall Vacuum Powered
Applicant COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View,  CA  94043
ContactCharles L Rose
CorrespondentCharles L Rose
COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View,  CA  94043
Product CodeGCX  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-29
Decision Date1991-04-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888937019940 K910377 000
00888937014440 K910377 000
00888937014327 K910377 000
00888937014242 K910377 000
20888937000058 K910377 000

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