The following data is part of a premarket notification filed by Equashield Medical Ltd with the FDA for Equashield System Protective Plus.
| Device ID | K101940 |
| 510k Number | K101940 |
| Device Name: | EQUASHIELD SYSTEM PROTECTIVE PLUS |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | EQUASHIELD MEDICAL LTD TEFEN INDUSTRIAL PARK P.O. B 12 IL 24959 |
| Contact | Elissa Burg |
| Correspondent | Elissa Burg EQUASHIELD MEDICAL LTD TEFEN INDUSTRIAL PARK P.O. B 12 IL 24959 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2010-11-19 |
| Summary: | summary |