The following data is part of a premarket notification filed by Elcam Medical Acal with the FDA for Induction And Sampling Manifold (or Stopcock).
| Device ID | K032393 |
| 510k Number | K032393 |
| Device Name: | INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) |
| Classification | Stopcock, I.v. Set |
| Applicant | ELCAM MEDICAL ACAL 7600 NORTH 15TH STREET SUITE 217 Phoenix, AZ 85020 |
| Contact | Bruce Ward |
| Correspondent | Bruce Ward ELCAM MEDICAL ACAL 7600 NORTH 15TH STREET SUITE 217 Phoenix, AZ 85020 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-09-12 |
| Summary: | summary |