The following data is part of a premarket notification filed by Medcorp Intl. with the FDA for Medcorp Flow I.v. Regulator Extension Set.
| Device ID | K971004 |
| 510k Number | K971004 |
| Device Name: | MEDCORP FLOW I.V. REGULATOR EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDCORP INTL. 25612 STRATFORD PLACE Laguna Hills, CA 92653 -7509 |
| Contact | Dave Berberian |
| Correspondent | Dave Berberian MEDCORP INTL. 25612 STRATFORD PLACE Laguna Hills, CA 92653 -7509 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-19 |
| Decision Date | 1997-10-02 |
| Summary: | summary |