The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Dermapoints Model 100 Therapeutic Massager.
Device ID | K881080 |
510k Number | K881080 |
Device Name: | DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER |
Classification | Massager, Therapeutic, Manual |
Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Product Code | LYG |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-14 |
Decision Date | 1988-07-21 |