The following data is part of a premarket notification filed by Acell, Inc with the FDA for Matristem Surgery Matrix Rs, Psm, Psmx, Matristem Pelvic Floor Matrix.
Device ID | K141084 |
510k Number | K141084 |
Device Name: | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix |
Classification | Mesh, Surgical |
Applicant | ACELL, INC 6640 ELI WHITNEY DR SUITE 200 Columbia, MD 21046 |
Contact | Salman Elmi |
Correspondent | Salman Elmi ACELL, INC 6640 ELI WHITNEY DR SUITE 200 Columbia, MD 21046 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-28 |
Decision Date | 2015-06-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00386190001295 | K141084 | 000 |
00386190000397 | K141084 | 000 |
00386190000380 | K141084 | 000 |
00386190000373 | K141084 | 000 |
00386190000366 | K141084 | 000 |
00386190000359 | K141084 | 000 |
00386190000342 | K141084 | 000 |
00386190000335 | K141084 | 000 |
00386190000304 | K141084 | 000 |
00386190000298 | K141084 | 000 |
00386190000281 | K141084 | 000 |
00386190000274 | K141084 | 000 |
00386190000267 | K141084 | 000 |
00386190000403 | K141084 | 000 |
00386190000410 | K141084 | 000 |
00386190001288 | K141084 | 000 |
00386190001271 | K141084 | 000 |
00386190001264 | K141084 | 000 |
00386190001257 | K141084 | 000 |
00386190000861 | K141084 | 000 |
00386190000854 | K141084 | 000 |
00386190000847 | K141084 | 000 |
00386190000830 | K141084 | 000 |
00386190000533 | K141084 | 000 |
00386190000441 | K141084 | 000 |
00386190000434 | K141084 | 000 |
00386190000427 | K141084 | 000 |
00386190000250 | K141084 | 000 |