The following data is part of a premarket notification filed by Surgitek with the FDA for Surgitek Intra-span Intraoperative Tissue Expander.
| Device ID | K902349 |
| 510k Number | K902349 |
| Device Name: | SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER |
| Classification | Expander, Surgical, Skin Graft |
| Applicant | SURGITEK 3003 ROLLIE GATES DR. Paso Robles, CA 93446 |
| Contact | A Salisbury |
| Correspondent | A Salisbury SURGITEK 3003 ROLLIE GATES DR. Paso Robles, CA 93446 |
| Product Code | FZW |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-25 |
| Decision Date | 1990-09-05 |