The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for .22 & 1.2 Micron Iv Filters.
| Device ID | K894954 |
| 510k Number | K894954 |
| Device Name: | .22 & 1.2 MICRON IV FILTERS |
| Classification | Filter, Infusion Line |
| Applicant | CHURCHILL MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham, PA 19044 |
| Contact | Joel A Marcus |
| Correspondent | Joel A Marcus CHURCHILL MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham, PA 19044 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-04 |
| Decision Date | 1989-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884002066 | K894954 | 000 |
| 30849884002028 | K894954 | 000 |
| 30849884002776 | K894954 | 000 |
| 30849884000505 | K894954 | 000 |
| 30849884004329 | K894954 | 000 |
| 30849884002608 | K894954 | 000 |
| 30849884005036 | K894954 | 000 |