The following data is part of a premarket notification filed by Hosmer Dorrance Corp. with the FDA for 4-bar Knee-shin Set-up.
Device ID | K761313 |
510k Number | K761313 |
Device Name: | 4-BAR KNEE-SHIN SET-UP |
Classification | Exerciser, Non-measuring |
Applicant | HOSMER DORRANCE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ION |
CFR Regulation Number | 890.5370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-12-13 |
Decision Date | 1977-01-10 |