COOK ULTRA QUIET VACUUM PUMP & REGULATOR

Accessory, Assisted Reproduction

COOK UROLOGICAL, INC.

The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Ultra Quiet Vacuum Pump & Regulator.

Pre-market Notification Details

Device IDK992070
510k NumberK992070
Device Name:COOK ULTRA QUIET VACUUM PUMP & REGULATOR
ClassificationAccessory, Assisted Reproduction
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
ContactBrenda Davis
CorrespondentBrenda Davis
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
Product CodeMQG  
CFR Regulation Number884.6120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-18
Decision Date1999-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00827002516076 K992070 000
00827002492752 K992070 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.