The following data is part of a premarket notification filed by Mauch Laboratories, Inc. with the FDA for Ankle/foot External.
| Device ID | K820505 |
| 510k Number | K820505 |
| Device Name: | ANKLE/FOOT EXTERNAL |
| Classification | Component, External, Limb, Ankle/foot |
| Applicant | MAUCH LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ISH |
| CFR Regulation Number | 890.3420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-25 |
| Decision Date | 1982-03-08 |