The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Progel(tm), Models 8630 And 8635.
Device ID | K882887 |
510k Number | K882887 |
Device Name: | PROGEL(TM), MODELS 8630 AND 8635 |
Classification | Electrode, Cutaneous |
Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Contact | Bruce Macfarlane,phd |
Correspondent | Bruce Macfarlane,phd MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-11 |
Decision Date | 1988-09-29 |