The following data is part of a premarket notification filed by Martin Medical with the FDA for Adult Walking Heel Product No. 4183-130.
Device ID | K873716 |
510k Number | K873716 |
Device Name: | ADULT WALKING HEEL PRODUCT NO. 4183-130 |
Classification | Electrode, Pacemaker, Temporary |
Applicant | MARTIN MEDICAL 36270 W. 103RD ST. P.O. BOX 590 Desoto, KS 66018 |
Contact | Randy Kilburn |
Correspondent | Randy Kilburn MARTIN MEDICAL 36270 W. 103RD ST. P.O. BOX 590 Desoto, KS 66018 |
Product Code | LDF |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-15 |
Decision Date | 1987-10-02 |