The following data is part of a premarket notification filed by N.m.b. Medical Applications, Ltd. with the FDA for Piccolo Composite Plate System.
Device ID | K102597 |
510k Number | K102597 |
Device Name: | PICCOLO COMPOSITE PLATE SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | N.M.B. MEDICAL APPLICATIONS, LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 46724 |
Contact | Hila Wachsler-avrahami |
Correspondent | Hila Wachsler-avrahami N.M.B. MEDICAL APPLICATIONS, LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 46724 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-10 |
Decision Date | 2011-02-24 |
Summary: | summary |