The following data is part of a premarket notification filed by Prime Medical Products, Inc. with the FDA for Prime Pca And Pca/continuous Systems.
| Device ID | K920637 |
| 510k Number | K920637 |
| Device Name: | PRIME PCA AND PCA/CONTINUOUS SYSTEMS |
| Classification | Pump, Infusion, Pca |
| Applicant | PRIME MEDICAL PRODUCTS, INC. 12472 PARK AVENUE Windermere, FL 34786 |
| Contact | Brian D Zdeb |
| Correspondent | Brian D Zdeb PRIME MEDICAL PRODUCTS, INC. 12472 PARK AVENUE Windermere, FL 34786 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-12 |
| Decision Date | 1993-01-15 |