The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Slip-on Sandals For Measuring Shortness.
Device ID | K823654 |
510k Number | K823654 |
Device Name: | SLIP-ON SANDALS FOR MEASURING SHORTNESS |
Classification | Orthosis, Corrective Shoe |
Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNP |
CFR Regulation Number | 890.3475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-06 |
Decision Date | 1983-01-21 |