The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Cyclopac Tens.
| Device ID | K801855 |
| 510k Number | K801855 |
| Device Name: | CYCLOPAC TENS |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | DOW CORNING WRIGHT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-04 |
| Decision Date | 1980-08-13 |