The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Brand Intravaginal Tarsette.
| Device ID | K771548 |
| 510k Number | K771548 |
| Device Name: | SILASTIC BRAND INTRAVAGINAL TARSETTE |
| Classification | Pessary, Vaginal |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-12 |
| Decision Date | 1977-11-07 |