The following data is part of a premarket notification filed by David Hendricks, C.p.o. with the FDA for Cash Orthosis.
Device ID | K812099 |
510k Number | K812099 |
Device Name: | CASH ORTHOSIS |
Classification | Orthosis, Lumbo-sacral |
Applicant | DAVID HENDRICKS, C.P.O. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPY |
CFR Regulation Number | 890.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-24 |
Decision Date | 1981-08-13 |