The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Pressure Activated Check Valve.
Device ID | K011888 |
510k Number | K011888 |
Device Name: | PRESSURE ACTIVATED CHECK VALVE |
Classification | Set, Administration, Intravascular |
Applicant | CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
Contact | Keith Paluch |
Correspondent | Keith Paluch CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-18 |
Decision Date | 2001-09-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30849884001885 | K011888 | 000 |
30849884006217 | K011888 | 000 |