The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Tex-span Textured Tissue Expander.
| Device ID | K903448 |
| 510k Number | K903448 |
| Device Name: | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | MEDICAL ENGINEERING CORP. 3003 ROLLIE GATES DR. Paso Robles, CA 93446 |
| Contact | Sally A Salisbury |
| Correspondent | Sally A Salisbury MEDICAL ENGINEERING CORP. 3003 ROLLIE GATES DR. Paso Robles, CA 93446 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1991-01-14 |