The following data is part of a premarket notification filed by J & J Solutions, Inc. D/b/a/ Corvida Medical with the FDA for Halo Closed Vial Adaptor (multiple Models Based On 13, 20 Or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor.
| Device ID | K180574 |
| 510k Number | K180574 |
| Device Name: | Halo Closed Vial Adaptor (Multiple Models Based On 13, 20 Or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | J & J Solutions, Inc. D/b/a/ Corvida Medical 2945 Lone Oak Drive, Suite 150 Eagan, MN 55121 |
| Contact | Dana Schramm |
| Correspondent | Dana Schramm J & J Solutions, Inc. D/b/a/ Corvida Medical 2945 Lone Oak Drive, Suite 150 Eagan, MN 55121 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-08-17 |
| Summary: | summary |