The following data is part of a premarket notification filed by Medegen Inc. with the FDA for Medegen Pressure Rated Extension Sets.
| Device ID | K083472 |
| 510k Number | K083472 |
| Device Name: | MEDEGEN PRESSURE RATED EXTENSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDEGEN INC. 930 WANAMAKER AVE. Ontario, CA 91761 -8151 |
| Contact | Tim L Truitt |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2008-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885403274654 | K083472 | 000 |
| 20885403274500 | K083472 | 000 |
| 20885403236720 | K083472 | 000 |
| 20885403236614 | K083472 | 000 |