The following data is part of a premarket notification filed by Eclipse Medcorp, Llc with the FDA for Eclipse Dermaflex Cannula.
| Device ID | K200017 |
| 510k Number | K200017 |
| Device Name: | Eclipse DermaFlex Cannula |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Eclipse MedCorp, LLC 5916 Stone Creek Drive Suite#120 The Colony, TX 75056 |
| Contact | John Tepper |
| Correspondent | Julie Summerville Eclipse MedCorp, LLC 5916 Stone Creek Drive Suite#120 The Colony, TX 75056 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-03 |
| Decision Date | 2020-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10853602008526 | K200017 | 000 |
| 10853602008519 | K200017 | 000 |
| 10853602008502 | K200017 | 000 |
| 10853602008496 | K200017 | 000 |
| 10853602008489 | K200017 | 000 |
| 10853602008472 | K200017 | 000 |
| 00853602008468 | K200017 | 000 |
| 10853602008458 | K200017 | 000 |