The following data is part of a premarket notification filed by Medimop Medical Projects, Ltd. with the FDA for Needleless Transfer Device.
| Device ID | K001831 |
| 510k Number | K001831 |
| Device Name: | NEEDLELESS TRANSFER DEVICE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MEDIMOP MEDICAL PROJECTS, LTD. 815 CONNECTION AVENUE, N.W. Washington, DC 20006 -4004 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler MEDIMOP MEDICAL PROJECTS, LTD. 815 CONNECTION AVENUE, N.W. Washington, DC 20006 -4004 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-16 |
| Decision Date | 2000-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290108240959 | K001831 | 000 |