The following data is part of a premarket notification filed by Acell, Inc with the FDA for Acell Ubm Surgical Mesh.
Device ID | K040621 |
510k Number | K040621 |
Device Name: | ACELL UBM SURGICAL MESH |
Classification | Mesh, Surgical |
Applicant | ACELL, INC 5610 WISCONSIN AVE #304 Chevy Chase, MD 20815 |
Contact | Patsy J Trisler |
Correspondent | Patsy J Trisler ACELL, INC 5610 WISCONSIN AVE #304 Chevy Chase, MD 20815 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-09 |
Decision Date | 2004-04-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00386190001769 | K040621 | 000 |
00386190001752 | K040621 | 000 |
00386190001745 | K040621 | 000 |
00386190001738 | K040621 | 000 |