The following data is part of a premarket notification filed by Lysonix, Inc. with the FDA for Lysonix Aspiration Pump.
Device ID | K980454 |
510k Number | K980454 |
Device Name: | LYSONIX ASPIRATION PUMP |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | LYSONIX, INC. 1170 MARK AVE. Carpinteria, CA 93013 |
Contact | Ronald F Lagerquist |
Correspondent | Ronald F Lagerquist LYSONIX, INC. 1170 MARK AVE. Carpinteria, CA 93013 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-05 |
Decision Date | 1998-03-18 |
Summary: | summary |