The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for If-ii (tm), Model 9800.
Device ID | K883462 |
510k Number | K883462 |
Device Name: | IF-II (TM), MODEL 9800 |
Classification | Interferential Current Therapy |
Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Contact | A Macfarlane |
Correspondent | A Macfarlane MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-15 |
Decision Date | 1989-05-24 |