The following data is part of a premarket notification filed by Pantheon Products, Inc. with the FDA for Sheets Lyophilized Collagen Heyedrator.
| Device ID | K861456 |
| 510k Number | K861456 |
| Device Name: | SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR |
| Classification | Pad, Eye |
| Applicant | PANTHEON PRODUCTS, INC. ROUTE 1 BOX 209W Odessa, TX 79766 |
| Contact | Raquel Sheets |
| Correspondent | Raquel Sheets PANTHEON PRODUCTS, INC. ROUTE 1 BOX 209W Odessa, TX 79766 |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-18 |
| Decision Date | 1986-07-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR 73576683 1424551 Dead/Cancelled |
PANTHEON PRODUCTS, INC. 1986-01-07 |