The following data is part of a premarket notification filed by Applied Medical Research with the FDA for Optional Accessory Foot Switch Model 100.
Device ID | K790322 |
510k Number | K790322 |
Device Name: | OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 |
Classification | Controller, Foot, Handpiece And Cord |
Applicant | APPLIED MEDICAL RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBW |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-15 |
Decision Date | 1979-05-14 |