The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Cook Ecm Powder.
| Device ID | K152033 |
| 510k Number | K152033 |
| Device Name: | Cook ECM Powder |
| Classification | Dressing, Wound, Collagen |
| Applicant | Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
| Contact | Perry W Guinn |
| Correspondent | Katie Molland Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
| 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 | 2015-07-22 |
| Decision Date | 2015-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20827002448548 | K152033 | 000 |
| 20827002448531 | K152033 | 000 |
| 20827002448524 | K152033 | 000 |
| 20827002448517 | K152033 | 000 |
| 20827002587643 | K152033 | 000 |
| 20827002587636 | K152033 | 000 |
| 20827002587629 | K152033 | 000 |