SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES

Chamber, Hyperbaric

FINK ENGINEERING PTY LTD

The following data is part of a premarket notification filed by Fink Engineering Pty Ltd with the FDA for Sl8/dl8/tl20 Hyperbaric Oxygen Treatment Facilities.

Pre-market Notification Details

Device IDK031649
510k NumberK031649
Device Name:SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
ClassificationChamber, Hyperbaric
Applicant FINK ENGINEERING PTY LTD 18111 COPPER RIDGE DRIVE San Antonio,  TX  78259
ContactW.t. Workman
CorrespondentW.t. Workman
FINK ENGINEERING PTY LTD 18111 COPPER RIDGE DRIVE San Antonio,  TX  78259
Product CodeCBF  
CFR Regulation Number868.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductYes
Date Received2003-05-28
Decision Date2003-12-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B718DL82130 K031649 000
B718DL82030 K031649 000

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