The following data is part of a premarket notification filed by Femcare Ltd. with the FDA for Add-a-cath.
Device ID | K884061 |
510k Number | K884061 |
Device Name: | ADD-A-CATH |
Classification | Catheter, Suprapubic (and Accessories) |
Applicant | FEMCARE LTD. BAR LANE INDUSTRIAL PARK BAR LANE, BASFORD Nottingham, England, GB Ng6 0ja |
Contact | Andrew Martin |
Correspondent | Andrew Martin FEMCARE LTD. BAR LANE INDUSTRIAL PARK BAR LANE, BASFORD Nottingham, England, GB Ng6 0ja |
Product Code | KOB |
CFR Regulation Number | 876.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-26 |
Decision Date | 1988-10-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H671SFS181011 | K884061 | 000 |
H671SFS168511 | K884061 | 000 |
H671SFS161001 | K884061 | 000 |
H671SFS141041 | K884061 | 000 |
H671SFS128521 | K884061 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ADD-A-CATH 80987444 0987444 Dead/Cancelled |
Kendall Company, The 0000-00-00 |
ADD-A-CATH 74124239 1668411 Dead/Cancelled |
Kendall Company, The 1990-12-17 |
ADD-A-CATH 73738468 not registered Dead/Abandoned |
FEMCARE LIMITED 1988-07-06 |