The following data is part of a premarket notification filed by Martin Medical with the FDA for American Orthopaedic Cast Cutter, Model 0295-200.
Device ID | K861074 |
510k Number | K861074 |
Device Name: | AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200 |
Classification | Component, Cast |
Applicant | MARTIN MEDICAL 36270 W. 103RD ST. P.O. BOX 590 Desoto, KS 66018 |
Contact | Randy S Kilburn |
Correspondent | Randy S Kilburn MARTIN MEDICAL 36270 W. 103RD ST. P.O. BOX 590 Desoto, KS 66018 |
Product Code | LGF |
CFR Regulation Number | 888.5940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-21 |
Decision Date | 1986-03-28 |