The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for Sgarlato Flexible Hinge Toe Implant.
| Device ID | K905795 |
| 510k Number | K905795 |
| Device Name: | SGARLATO FLEXIBLE HINGE TOE IMPLANT |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | SGARLATO LABORATORIES, INC. 100 O'CONNOR DR, SUITE 18 San Jose, CA 95128 |
| Contact | Thomas E Sgarlato |
| Correspondent | Thomas E Sgarlato SGARLATO LABORATORIES, INC. 100 O'CONNOR DR, SUITE 18 San Jose, CA 95128 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-05-29 |