LIFETECH CASSETTE

Chamber, Oxygen, Topical, Extremity

LIFETECH SYSTEMS, INC.

The following data is part of a premarket notification filed by Lifetech Systems, Inc. with the FDA for Lifetech Cassette.

Pre-market Notification Details

Device IDK960756
510k NumberK960756
Device Name:LIFETECH CASSETTE
ClassificationChamber, Oxygen, Topical, Extremity
Applicant LIFETECH SYSTEMS, INC. 11350 RANDOM HILLS RD. #800 Fairfax,  VA  22030
ContactJohn Oberst
CorrespondentJohn Oberst
LIFETECH SYSTEMS, INC. 11350 RANDOM HILLS RD. #800 Fairfax,  VA  22030
Product CodeKPJ  
CFR Regulation Number878.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-23
Decision Date1997-08-29
Summary:summary

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