The following data is part of a premarket notification filed by Plastmed, Ltd. with the FDA for Equalshield Luer Lock Connector Pair.
| Device ID | K091389 |
| 510k Number | K091389 |
| Device Name: | EQUALSHIELD LUER LOCK CONNECTOR PAIR |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | PLASTMED, LTD. BUILDING 7 P.O.B. 26 Tefen Industrial Park, IL 24959 |
| Contact | Elissa Burg |
| Correspondent | Elissa Burg PLASTMED, LTD. BUILDING 7 P.O.B. 26 Tefen Industrial Park, IL 24959 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-11 |
| Decision Date | 2009-10-22 |
| Summary: | summary |