The following data is part of a premarket notification filed by Emblation Ltd with the FDA for Swift System.
Device ID | K181941 |
510k Number | K181941 |
Device Name: | Swift System |
Classification | System, Ablation, Microwave And Accessories |
Applicant | Emblation Ltd Forrester Lodge Alloa, GB Fk10 2hu |
Contact | Mairi Macfadyen |
Correspondent | Mairi Macfadyen Emblation Ltd Forrester Lodge Alloa, GB Fk10 2hu |
Product Code | NEY |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-20 |
Decision Date | 2018-10-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060652910046 | K181941 | 000 |
05060652910039 | K181941 | 000 |
05060652910022 | K181941 | 000 |
05060652910015 | K181941 | 000 |
05060652910008 | K181941 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SWIFT SYSTEM 73434415 not registered Dead/Abandoned |
HARBOR FEDERAL SAVINGS AND LOAN ASSOCIATION 1983-07-13 |