The following data is part of a premarket notification filed by N.m.b. Medical Applications, Ltd. with the FDA for Quantum M Composite Nailing System.
Device ID | K091425 |
510k Number | K091425 |
Device Name: | QUANTUM M COMPOSITE NAILING SYSTEM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | N.M.B. MEDICAL APPLICATIONS, LTD. 555 THIRTEENTH ST. NW Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan N.M.B. MEDICAL APPLICATIONS, LTD. 555 THIRTEENTH ST. NW Washington, DC 20004 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-05-13 |
Decision Date | 2010-01-21 |
Summary: | summary |