The following data is part of a premarket notification filed by Acell, Inc with the FDA for Acell Ubm Surgical Mesh Ml And Mlplus.
Device ID | K041140 |
510k Number | K041140 |
Device Name: | ACELL UBM SURGICAL MESH ML AND MLPLUS |
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 | 2004-04-30 |
Decision Date | 2004-07-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00386190001813 | K041140 | 000 |
00386190000892 | K041140 | 000 |
00386190000526 | K041140 | 000 |
00386190000519 | K041140 | 000 |
00386190000502 | K041140 | 000 |
00386190000496 | K041140 | 000 |
00386190000489 | K041140 | 000 |
00386190000472 | K041140 | 000 |
00386190000465 | K041140 | 000 |
00386190000908 | K041140 | 000 |
00386190000915 | K041140 | 000 |
00386190000922 | K041140 | 000 |
00386190001790 | K041140 | 000 |
00386190001585 | K041140 | 000 |
00386190001578 | K041140 | 000 |
00386190001561 | K041140 | 000 |
00386190001554 | K041140 | 000 |
00386190001547 | K041140 | 000 |
00386190001530 | K041140 | 000 |
00386190001523 | K041140 | 000 |
00386190000458 | K041140 | 000 |