The following data is part of a premarket notification filed by Arc Medical, Inc. with the FDA for Circuit Guard.
Device ID | K982239 |
510k Number | K982239 |
Device Name: | CIRCUIT GUARD |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | ARC MEDICAL, INC. 322 PATTERSON AVE. Scottdale, GA 30079 |
Contact | Harold B Norris |
Correspondent | Harold B Norris ARC MEDICAL, INC. 322 PATTERSON AVE. Scottdale, GA 30079 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-23 |
Decision Date | 1998-08-14 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CIRCUIT GUARD 74475676 1892861 Dead/Cancelled |
D. & E. Soth Holdings, Inc. 1994-01-04 |
CIRCUIT GUARD 73600484 not registered Dead/Abandoned |
MIKE AND CAROL MULANAX 1986-05-23 |
CIRCUIT GUARD 72295336 0894485 Live/Registered |
HARVEY HUBBELL, INCORPORATED 1968-04-10 |