The following data is part of a premarket notification filed by Lifetech Systems, Inc. with the FDA for Lifetech Cassette.
Device ID | K960756 |
510k Number | K960756 |
Device Name: | LIFETECH CASSETTE |
Classification | Chamber, Oxygen, Topical, Extremity |
Applicant | LIFETECH SYSTEMS, INC. 11350 RANDOM HILLS RD. #800 Fairfax, VA 22030 |
Contact | John Oberst |
Correspondent | John Oberst LIFETECH SYSTEMS, INC. 11350 RANDOM HILLS RD. #800 Fairfax, VA 22030 |
Product Code | KPJ |
CFR Regulation Number | 878.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-23 |
Decision Date | 1997-08-29 |
Summary: | summary |