The following data is part of a premarket notification filed by Teva Medical Ltd., Migada Plant with the FDA for Tevadaptor Closed Drug Reconstitution And Transfer System.
| Device ID | K141448 |
| 510k Number | K141448 |
| Device Name: | TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | TEVA MEDICAL LTD., MIGADA PLANT PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Contact | Roger L Gray |
| Correspondent | Roger L Gray TEVA MEDICAL LTD., MIGADA PLANT PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27298119121137 | K141448 | 000 |
| 27298119121120 | K141448 | 000 |
| 27298119121199 | K141448 | 000 |
| 27298119121182 | K141448 | 000 |
| 27298119121144 | K141448 | 000 |
| 27298119121113 | K141448 | 000 |
| 37290115921138 | K141448 | 000 |
| 37290115921145 | K141448 | 000 |