The following data is part of a premarket notification filed by Shikani Medical, Llc with the FDA for Shikani Speaking Valve.
| Device ID | K100995 |
| 510k Number | K100995 |
| Device Name: | SHIKANI SPEAKING VALVE |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | SHIKANI MEDICAL, LLC 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden SHIKANI MEDICAL, LLC 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-09 |
| Decision Date | 2010-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866035000312 | K100995 | 000 |
| 00866035000305 | K100995 | 000 |