The following data is part of a premarket notification filed by Premier Brands Of America, Inc. with the FDA for Premier Sterile Saline Wound Wash, Models 210 Ml, Wwm.
| Device ID | K090848 |
| 510k Number | K090848 |
| Device Name: | PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM |
| Classification | Lavage, Jet |
| Applicant | PREMIER BRANDS OF AMERICA, INC. 120 PEARL ST. Mount Vernon, NY 10550 |
| Contact | Mack Cauthen |
| Correspondent | Mack Cauthen PREMIER BRANDS OF AMERICA, INC. 120 PEARL ST. Mount Vernon, NY 10550 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-06-17 |
| Summary: | summary |