The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Tendon Passer H.p..
| Device ID | K811679 |
| 510k Number | K811679 |
| Device Name: | SILASTIC TENDON PASSER H.P. |
| Classification | Passer |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HWQ |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-15 |
| Decision Date | 1981-07-10 |