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 Number | 878.5650
|
Classification Product Code |
|
Date Received | 02/23/1996 |
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
|
|
|