The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Trochanter Mesh.
Device ID | K945027 |
510k Number | K945027 |
Device Name: | TROCHANTER MESH |
Classification | Mesh, Surgical, Metal |
Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Contact | Shari L Jeffers |
Correspondent | Shari L Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Product Code | EZX |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-13 |
Decision Date | 1995-02-01 |