The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Manifold With Extension Set.
| Device ID | K982368 |
| 510k Number | K982368 |
| Device Name: | MANIFOLD WITH EXTENSION SET |
| Classification | Stopcock, I.v. Set |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Lynn M Rodarti |
| Correspondent | Lynn M Rodarti INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-07 |
| Decision Date | 1998-07-31 |
| Summary: | summary |