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 |