The following data is part of a premarket notification filed by Patrin Pharma with the FDA for Hy-chlo(tm)wound Scrub.
| Device ID | K113312 |
| 510k Number | K113312 |
| Device Name: | HY-CHLO(TM)WOUND SCRUB |
| Classification | Lavage, Jet |
| Applicant | PATRIN PHARMA 7817 BABB AVE. Skokie, IL 60077 |
| Contact | Jay S Trivedi |
| Correspondent | Jay S Trivedi PATRIN PHARMA 7817 BABB AVE. Skokie, IL 60077 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-09 |
| Decision Date | 2012-08-21 |
| Summary: | summary |