The following data is part of a premarket notification filed by Medimop Medical Projects, Ltd. with the FDA for Modification To Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder And Pre-attached Needle.
| Device ID | K001293 |
| 510k Number | K001293 |
| Device Name: | MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-24 |
| Decision Date | 2000-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290108241079 | K001293 | 000 |
| 27290108240515 | K001293 | 000 |
| 27290108240348 | K001293 | 000 |
| 27290108240324 | K001293 | 000 |
| 27290108240300 | K001293 | 000 |
| 27290108240188 | K001293 | 000 |
| 27290108240140 | K001293 | 000 |
| 27290108240096 | K001293 | 000 |
| 27290108240072 | K001293 | 000 |
| 27290108240010 | K001293 | 000 |
| 27290108240003 | K001293 | 000 |
| 07290108241105 | K001293 | 000 |
| 27290108240522 | K001293 | 000 |
| 27290108240553 | K001293 | 000 |
| 27290108241055 | K001293 | 000 |
| 27290108241048 | K001293 | 000 |
| 27290108240928 | K001293 | 000 |
| 27290108240881 | K001293 | 000 |
| 27290108240874 | K001293 | 000 |
| 27290108240782 | K001293 | 000 |
| 27290108240706 | K001293 | 000 |
| 27290108240669 | K001293 | 000 |
| 27290108240591 | K001293 | 000 |
| 27290108240584 | K001293 | 000 |
| 27290108240560 | K001293 | 000 |
| 07290108241099 | K001293 | 000 |