The following data is part of a premarket notification filed by Mellenair Ent., Inc. with the FDA for Rem-air.
Device ID | K924686 |
510k Number | K924686 |
Device Name: | REM-AIR |
Classification | Bed, Air Fluidized |
Applicant | MELLENAIR ENT., INC. 2107 SAN VICENTE AVE. Long Beach, CA 90815 |
Contact | Anthony Dacosta |
Correspondent | Anthony Dacosta MELLENAIR ENT., INC. 2107 SAN VICENTE AVE. Long Beach, CA 90815 |
Product Code | INX |
CFR Regulation Number | 890.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-16 |
Decision Date | 1993-02-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REM-AIR 74326119 1810057 Dead/Cancelled |
MELLEN AIR MANUFACTURING, INC. 1992-10-27 |