The following data is part of a premarket notification filed by Neomedix Corp. with the FDA for Supraflow Console.
Device ID | K040239 |
510k Number | K040239 |
Device Name: | SUPRAFLOW CONSOLE |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | NEOMEDIX CORP. 27452 CALLE ARROYO San Juan Capistrano, CA 92675 -2748 |
Contact | Soheila Mirhashemi |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-02-02 |
Decision Date | 2004-02-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00854028002023 | K040239 | 000 |