The following data is part of a premarket notification filed by Warm & Form, Orthopedic Materials with the FDA for Head Halter.
Device ID | K830245 |
510k Number | K830245 |
Device Name: | HEAD HALTER |
Classification | Accessories, Traction |
Applicant | WARM & FORM, ORTHOPEDIC MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILZ |
CFR Regulation Number | 890.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-25 |
Decision Date | 1983-03-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEAD HALTER 85418713 not registered Dead/Abandoned |
The Sporn Company, Inc. 2011-09-09 |