The following data is part of a premarket notification filed by Solopak Medical Products, Inc. with the FDA for Solopak Paragon Infusor Pump And Infusion Set.
| Device ID | K963355 |
| 510k Number | K963355 |
| Device Name: | SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | SOLOPAK MEDICAL PRODUCTS, INC. 1840 INDUSTRIAL DR. SUITE 100 Libertyville, IL 60048 |
| Contact | Ron Haselhorst |
| Correspondent | Ron Haselhorst SOLOPAK MEDICAL PRODUCTS, INC. 1840 INDUSTRIAL DR. SUITE 100 Libertyville, IL 60048 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-26 |
| Decision Date | 1996-10-04 |
| Summary: | summary |