The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Intego Pet Infusion System, Source Administration Set, Patient Adminstratin Set Model Int Sys 100, Int Css, Int C.
| Device ID | K100798 |
| 510k Number | K100798 |
| Device Name: | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C |
| Classification | Pump, Infusion |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Susan Lynn Felix |
| Correspondent | Susan Lynn Felix MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2010-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258021324 | K100798 | 000 |
| 00616258009650 | K100798 | 000 |
| 00616258008653 | K100798 | 000 |
| 00616258020310 | K100798 | 000 |
| 00616258025834 | K100798 | 000 |
| 00616258025360 | K100798 | 000 |
| 00616258021379 | K100798 | 000 |