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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chamber, oxygen, topical, extremity
510(k) Number K960756
Device Name LIFETECH CASSETTE
Applicant
LIFETECH SYSTEMS, INC.
11350 RANDOM HILLS RD. #800
FAIRFAX,  VA  22030
Applicant Contact JOHN OBERST
Correspondent
LIFETECH SYSTEMS, INC.
11350 RANDOM HILLS RD. #800
FAIRFAX,  VA  22030
Correspondent Contact JOHN OBERST
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received02/23/1996
Decision Date 08/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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