The following data is part of a premarket notification filed by Advanced Medical Products, Inc. with the FDA for Advanced Medical Products Mes Tens.
Device ID | K852838 |
510k Number | K852838 |
Device Name: | ADVANCED MEDICAL PRODUCTS MES TENS |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | ADVANCED MEDICAL PRODUCTS, INC. 384 PRATT ST. Meriden, CT 06450 |
Contact | Charles A Garcia |
Correspondent | Charles A Garcia ADVANCED MEDICAL PRODUCTS, INC. 384 PRATT ST. Meriden, CT 06450 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-02 |
Decision Date | 1985-08-28 |