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 |