The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Perclot Topical.
| Device ID | K132105 |
| 510k Number | K132105 |
| Device Name: | PERCLOT TOPICAL |
| Classification | Dressing, Wound, Drug |
| Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Contact | Kimberly Dicono |
| Correspondent | Kimberly Dicono CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-08 |
| Decision Date | 2014-04-03 |
| Summary: | summary |