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 | K132899 |
| 510k Number | K132899 |
| Device Name: | EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) |
| Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Applicant | EQUASHIELD MEDICAL LTD 57 LAZY BROOK RD Monroe, CT 06468 |
| Contact | Raymond J Kelly, Iv |
| Correspondent | Raymond J Kelly, Iv EQUASHIELD MEDICAL LTD 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 | 2013-09-16 |
| Decision Date | 2014-05-13 |
| Summary: | summary |