The following data is part of a premarket notification filed by Epic Extremely, Llc with the FDA for Epic Extremely Small Staple.
| Device ID | K163226 |
| 510k Number | K163226 |
| Device Name: | EPIC Extremely Small Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | Epic Extremely, LLC 120 Marguerite Dr, Ste 301 Cranberry Twp, PA 16066 |
| Contact | Dan Schwartzbauer |
| Correspondent | Randy Schlemmer EPIC EXTREMITY, LLC 120 Marguerite Drive, Suite 301 Cranberry Twp, PA 16066 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-17 |
| Decision Date | 2017-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817577023192 | K163226 | 000 |
| 00817577023147 | K163226 | 000 |