The following data is part of a premarket notification filed by Nemectron Medical, Inc. with the FDA for Nemectrodyn Model 2 & Endovac 2 Power Muscle Stim..
Device ID | K854720 |
510k Number | K854720 |
Device Name: | NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. |
Classification | Stimulator, Muscle, Powered |
Applicant | NEMECTRON MEDICAL, INC. 28069 DIAZ RD., UNIT A Temecula, CA 92590 |
Contact | Juergen F Kopf |
Correspondent | Juergen F Kopf NEMECTRON MEDICAL, INC. 28069 DIAZ RD., UNIT A Temecula, CA 92590 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-22 |
Decision Date | 1986-03-10 |