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 | K170706 |
| 510k Number | K170706 |
| 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 Migdal Tefen, IL 24959 |
| Contact | Dorit Valal |
| Correspondent | Raymond Kelly Licensale Inc. 68 Southwoods Terrace Southbury, CT 06488 |
| Product Code | ONB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-08 |
| Decision Date | 2017-07-03 |
| Summary: | summary |