The following data is part of a premarket notification filed by Knight Medical, Inc. with the FDA for Kmi Oxy-ban.
Device ID | K883848 |
510k Number | K883848 |
Device Name: | KMI OXY-BAN |
Classification | Chamber, Oxygen, Topical, Extremity |
Applicant | KNIGHT MEDICAL, INC. 18120 AMMI TRAIL Houston, TX 77060 |
Contact | Kenneth E Clary |
Correspondent | Kenneth E Clary KNIGHT MEDICAL, INC. 18120 AMMI TRAIL Houston, TX 77060 |
Product Code | KPJ |
CFR Regulation Number | 878.5650 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-12 |
Decision Date | 1989-03-02 |