The following data is part of a premarket notification filed by Novamedix Ltd. with the FDA for A-v Impulse System.
Device ID | K914461 |
510k Number | K914461 |
Device Name: | A-V IMPULSE SYSTEM |
Classification | Sleeve, Limb, Compressible |
Applicant | NOVAMEDIX LTD. C/O POWELL-GOLDSTEIN FRAZ-MURP 1001 PENNSYLVANIA AVE., N.W. Washington, DC 20004 |
Contact | Thomas M Antone |
Correspondent | Thomas M Antone NOVAMEDIX LTD. C/O POWELL-GOLDSTEIN FRAZ-MURP 1001 PENNSYLVANIA AVE., N.W. Washington, DC 20004 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-07 |
Decision Date | 1992-04-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
A-V IMPULSE SYSTEM 75193078 2229887 Live/Registered |
CARDINAL HEALTH IRELAND UNLIMITED COMPANY 1996-11-01 |
A-V IMPULSE SYSTEM 73822940 1689685 Dead/Cancelled |
NOVAMEDIX LTD. 1989-09-01 |