The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Gamma Radiation Sterilization Precedure.
| Device ID | K781668 |
| 510k Number | K781668 |
| Device Name: | GAMMA RADIATION STERILIZATION PRECEDURE |
| Classification | Prosthesis, Finger, Constrained, Polymer |
| Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYJ |
| CFR Regulation Number | 888.3230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-28 |
| Decision Date | 1978-11-03 |