The following data is part of a premarket notification filed by Teva Medical Ltd., Migada Plant with the FDA for Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/ Ultrasite Injection Site.
| Device ID | K141306 |
| 510k Number | K141306 |
| Device Name: | TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE |
| Classification | Set, Administration, Intravascular |
| Applicant | TEVA MEDICAL LTD., MIGADA PLANT PIAZZA ALBANIA 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray TEVA MEDICAL LTD., MIGADA PLANT PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-19 |
| Decision Date | 2014-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27298119121168 | K141306 | 000 |
| 27298119121151 | K141306 | 000 |