FDA.reportPublic FDA data

510(k) K002596

Device
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
Applicant
Gebauer Co.
510(k) number
K002596
Product code
MLY
Decision
Substantially Equivalent (SESE)
Decision date
2001-02-15
Date received
2000-08-21
Classification name
Vapocoolant Device
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DENISE E SPELLMAN
Address
9410 St. Catherine Ave. Cleveland OH US 44104 44104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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