The following data is part of a premarket notification filed by Medimop Medical Projects, Ltd. with the FDA for Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder And Preattached Needle.
| Device ID | K963583 |
| 510k Number | K963583 |
| Device Name: | MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MEDIMOP MEDICAL PROJECTS, LTD. 4 MAYEZIRA ST. P.O.BOX 2499 Raanana, IL 43000 |
| Contact | Freddy Zinger |
| Correspondent | Freddy Zinger MEDIMOP MEDICAL PROJECTS, LTD. 4 MAYEZIRA ST. P.O.BOX 2499 Raanana, IL 43000 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-06 |
| Decision Date | 1996-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290108241062 | K963583 | 000 |
| 27290108240430 | K963583 | 000 |
| 27290108240416 | K963583 | 000 |
| 27290108240331 | K963583 | 000 |
| 27290108240294 | K963583 | 000 |
| 27290108240270 | K963583 | 000 |
| 27290108240256 | K963583 | 000 |
| 27290108240249 | K963583 | 000 |
| 27290108240225 | K963583 | 000 |
| 27290108240218 | K963583 | 000 |
| 27290108240195 | K963583 | 000 |
| 27290108240171 | K963583 | 000 |
| 27290108240164 | K963583 | 000 |
| 27290108240157 | K963583 | 000 |
| 27290108240089 | K963583 | 000 |
| 272901080447 | K963583 | 000 |
| 27290108240454 | K963583 | 000 |
| 27290108240461 | K963583 | 000 |
| 27290108241031 | K963583 | 000 |
| 27290108241017 | K963583 | 000 |
| 27290108240973 | K963583 | 000 |
| 27290108240966 | K963583 | 000 |
| 27290108240942 | K963583 | 000 |
| 27290108240836 | K963583 | 000 |
| 27290108240829 | K963583 | 000 |
| 27290108240737 | K963583 | 000 |
| 27290108240652 | K963583 | 000 |
| 27290108240645 | K963583 | 000 |
| 27290108240638 | K963583 | 000 |
| 27290108240614 | K963583 | 000 |
| 27290108240485 | K963583 | 000 |
| 27290108240478 | K963583 | 000 |
| 07290108241211 | K963583 | 000 |