The following data is part of a premarket notification filed by Century Pharmaceuticals, Inc. with the FDA for Dakin's Antimicrobial Wound Cleanser, Model 0.0125% To 5%.
| Device ID | K090791 |
| 510k Number | K090791 |
| Device Name: | DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% |
| Classification | Dressing, Wound, Drug |
| Applicant | CENTURY PHARMACEUTICALS, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden CENTURY PHARMACEUTICALS, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-03-24 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304365306440 | K090791 | 000 |
| 00304365201615 | K090791 | 000 |
| 00304365200823 | K090791 | 000 |
| 00304361006436 | K090791 | 000 |
| 00304365312847 | K090791 | 000 |
| 00304365212840 | K090791 | 000 |
| 00304365200816 | K090791 | 000 |