The following data is part of a premarket notification filed by Manuco Manufacturing Co., Inc. with the FDA for Light Weight Aluminum Canes.
Device ID | K821402 |
510k Number | K821402 |
Device Name: | LIGHT WEIGHT ALUMINUM CANES |
Classification | Cane |
Applicant | MANUCO MANUFACTURING CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPS |
CFR Regulation Number | 890.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-21 |
Decision Date | 1982-04-21 |