The following data is part of a premarket notification filed by Mahe Medical Gmbh with the FDA for Mahe Fixation Plate And Screw System.
Device ID | K102845 |
510k Number | K102845 |
Device Name: | MAHE FIXATION PLATE AND SCREW SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | MAHE MEDICAL GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, Bw, GR 78532 |
Contact | Andrea Pecsi |
Correspondent | Andrea Pecsi MAHE MEDICAL GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, Bw, GR 78532 |
Product Code | HRS |
Subsequent Product Code | HTY |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-29 |
Decision Date | 2011-05-13 |
Summary: | summary |