The following data is part of a premarket notification filed by Acell, Inc with the FDA for Cytal Wound Matrix.
| Device ID | K152721 |
| 510k Number | K152721 |
| Device Name: | Cytal Wound Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | ACELL, INC 6640 ELI WHITNEY DR Columbia, MD 21046 |
| Contact | Thomas Gilbert |
| Correspondent | Thomas Gilbert ACELL, INC 6640 ELI WHITNEY DR Columbia, MD 21046 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2015-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386190001516 | K152721 | 000 |
| 00386190001059 | K152721 | 000 |
| 00386190001042 | K152721 | 000 |
| 00386190001035 | K152721 | 000 |
| 00386190001028 | K152721 | 000 |
| 00386190001011 | K152721 | 000 |
| 00386190001004 | K152721 | 000 |
| 00386190000991 | K152721 | 000 |
| 00386190000984 | K152721 | 000 |
| 00386190000977 | K152721 | 000 |
| 00386190000960 | K152721 | 000 |
| 00386190000953 | K152721 | 000 |
| 00386190000946 | K152721 | 000 |
| 00386190000939 | K152721 | 000 |
| 00386190000823 | K152721 | 000 |
| 00386190000816 | K152721 | 000 |
| 00386190001066 | K152721 | 000 |
| 00386190001073 | K152721 | 000 |
| 00386190001080 | K152721 | 000 |
| 00386190001509 | K152721 | 000 |
| 00386190001493 | K152721 | 000 |
| 00386190001486 | K152721 | 000 |
| 00386190001479 | K152721 | 000 |
| 00386190001462 | K152721 | 000 |
| 00386190001455 | K152721 | 000 |
| 00386190001448 | K152721 | 000 |
| 00386190001431 | K152721 | 000 |
| 00386190001424 | K152721 | 000 |
| 00386190001417 | K152721 | 000 |
| 00386190001400 | K152721 | 000 |
| 00386190001394 | K152721 | 000 |
| 00386190001110 | K152721 | 000 |
| 00386190001103 | K152721 | 000 |
| 00386190001097 | K152721 | 000 |
| 00386190000809 | K152721 | 000 |