The following data is part of a premarket notification filed by Pilling Weck Surgical with the FDA for Shikani-french Speaking Valve.
| Device ID | K982128 |
| 510k Number | K982128 |
| Device Name: | SHIKANI-FRENCH SPEAKING VALVE |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1998-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14026704534293 | K982128 | 000 |
| 14026704534231 | K982128 | 000 |
| 14026704534200 | K982128 | 000 |
| 14026704534170 | K982128 | 000 |
| 14026704534149 | K982128 | 000 |