The following data is part of a premarket notification filed by Equashield Medical Ltd with the FDA for Equashield Closed System Drug Transfer Device (cstd).
| Device ID | K150219 |
| 510k Number | K150219 |
| Device Name: | Equashield Closed System Drug Transfer Device (CSTD) |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | EQUASHIELD MEDICAL LTD TEFEN INDUSTRIAL PARK P.O. B 12 Migdal, IL 24959 |
| Contact | Raymond J Kelly |
| Correspondent | Raymond J Kelly Iv LICENSALE INC. 57 Lazy Brook Rd. Monroe, CT 06468 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-30 |
| Decision Date | 2015-11-05 |