The following data is part of a premarket notification filed by Sea-band Uk Ltd. with the FDA for Sea-band.
Device ID | K033268 |
510k Number | K033268 |
Device Name: | SEA-BAND |
Classification | Device, Acupressure |
Applicant | SEA-BAND UK LTD. BUSINESS & TECH. CENTER BESSEMER DRIVE Stevenage, Herts., GB Sg1 2dx |
Contact | Neil R Armstrong |
Correspondent | Neil R Armstrong SEA-BAND UK LTD. BUSINESS & TECH. CENTER BESSEMER DRIVE Stevenage, Herts., GB Sg1 2dx |
Product Code | MVV |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-09 |
Decision Date | 2004-01-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00050428269381 | K033268 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SEA-BAND 79081803 3919062 Live/Registered |
SEA-BAND LIMITED 2010-03-08 |