The following data is part of a premarket notification filed by Factor, Ii, Inc. with the FDA for Factor Ii Prosthetic Silicone Elastomer.
| Device ID | K880329 |
| 510k Number | K880329 |
| Device Name: | FACTOR II PROSTHETIC SILICONE ELASTOMER |
| Classification | Material, External Aesthetic Restoration, Used With Adhesive |
| Applicant | FACTOR, II, INC. P.O. BOX 1339 Lakeside, AZ 85929 |
| Contact | John Mcfall |
| Correspondent | John Mcfall FACTOR, II, INC. P.O. BOX 1339 Lakeside, AZ 85929 |
| Product Code | GBI |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-06-01 |