DYNAFLEX
Device, Anti-snoring
DYNAFLEX
The following data is part of a premarket notification filed by Dynaflex with the FDA for Dynaflex.
Pre-market Notification Details
| Device ID | K103076 |
| 510k Number | K103076 |
| Device Name: | DYNAFLEX |
| Classification | Device, Anti-snoring |
| Applicant | DYNAFLEX 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Stuart R Goldman |
| Correspondent | Stuart R Goldman DYNAFLEX 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-18 |
| Decision Date | 2011-02-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D84101511W | K103076 | 000 |
| D84101101R | K103076 | 000 |
| D8410056G19 | K103076 | 000 |
Trademark Results [DYNAFLEX]
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