The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Dosimetric Release Program - Admin. Set.
| Device ID | K823214 |
| 510k Number | K823214 |
| Device Name: | DOSIMETRIC RELEASE PROGRAM - ADMIN. SET |
| Classification | Set, Administration, Intravascular |
| Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-28 |
| Decision Date | 1983-01-12 |