The following data is part of a premarket notification filed by Go Medical Industries Pty. Ltd. with the FDA for V Set.
| Device ID | K900336 |
| 510k Number | K900336 |
| Device Name: | V SET |
| Classification | Set, Administration, Intravascular |
| Applicant | GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. Subiaco, Perth, AU 6008 |
| Contact | David Capes |
| Correspondent | David Capes GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. Subiaco, Perth, AU 6008 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09350902000136 | K900336 | 000 |
| 9350902000129 | K900336 | 000 |
| 9350902000082 | K900336 | 000 |
| 9350902000044 | K900336 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() V SET 75914139 not registered Dead/Abandoned |
Cotton, Jack 2000-02-10 |