The following data is part of a premarket notification filed by Colmed, Ltd. with the FDA for Pelimit.
Device ID | K792241 |
510k Number | K792241 |
Device Name: | PELIMIT |
Classification | Device, Warning, Overload, External Limb, Powered |
Applicant | COLMED, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IRN |
CFR Regulation Number | 890.5575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-07 |
Decision Date | 1979-11-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PELIMIT 73113542 1116325 Dead/Cancelled |
INSTITUT STRAUMANN AG 1977-01-24 |