The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Cms Iv Filters.
Device ID | K896333 |
510k Number | K896333 |
Device Name: | CMS 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 | 1989-11-03 |
Decision Date | 1990-01-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30849884006170 | K896333 | 000 |