The following data is part of a premarket notification filed by Martin Medical with the FDA for Cast Cutter, 115v Model No. 4183-106.
Device ID | K873719 |
510k Number | K873719 |
Device Name: | CAST CUTTER, 115V MODEL NO. 4183-106 |
Classification | Instrument, Cast Removal, Ac-powered |
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 | LGH |
CFR Regulation Number | 888.5960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-15 |
Decision Date | 1987-10-02 |