The following data is part of a premarket notification filed by Charter Medical, Ltd. with the FDA for Charter Medical, Ltd Mp 450 (40 Micron Filter).
| Device ID | K990310 |
| 510k Number | K990310 |
| Device Name: | CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) |
| Classification | Microfilter, Blood Transfusion |
| Applicant | CHARTER MEDICAL, LTD. 1805 SWARTHMORE AVE. Lakewood, NJ 08701 |
| Contact | David Heagle |
| Correspondent | David Heagle CHARTER MEDICAL, LTD. 1805 SWARTHMORE AVE. Lakewood, NJ 08701 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-01 |
| Decision Date | 1999-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817827024559 | K990310 | 000 |
| 00817827024542 | K990310 | 000 |
| 00817827024535 | K990310 | 000 |
| 00817827024528 | K990310 | 000 |
| 00817827024511 | K990310 | 000 |