The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Elcam Stopcocks And Manifolds.
| Device ID | K022895 |
| 510k Number | K022895 |
| Device Name: | ELCAM STOPCOCKS AND MANIFOLDS |
| Classification | Stopcock, I.v. Set |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-03 |
| Decision Date | 2002-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290102590036 | K022895 | 000 |
| 27290102590029 | K022895 | 000 |
| 40193489896825 | K022895 | 000 |