The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Minipac Personal Touch (tm).
Device ID | K854761 |
510k Number | K854761 |
Device Name: | MINIPAC PERSONAL TOUCH (TM) |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Contact | Macfarlane Phd |
Correspondent | Macfarlane Phd MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-27 |
Decision Date | 1986-02-14 |