The following data is part of a premarket notification filed by College Park Industries, Inc. with the FDA for Espire Elbow Pro, Espire Elbow Hybrid.
| Device ID | K182757 |
| 510k Number | K182757 |
| Device Name: | Espire Elbow Pro, Espire Elbow Hybrid |
| Classification | Electrode, Cutaneous |
| Applicant | College Park Industries, Inc. 27955 College Park Drive Warren, MI 48088 |
| Contact | Deborah Mackmin |
| Correspondent | Ken Pilgrim Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2018-11-29 |
| Summary: | summary |