The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Renasys Foam Npwt Wound Dressing Kits With Suction Pad; Renasys Gauze Npwt Wound Dressing Kits With Suction Pad; Renasys.
| Device ID | K110647 |
| 510k Number | K110647 |
| Device Name: | RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. St. Petersburg, FL 33716 |
| Contact | Laura Reynolds |
| Correspondent | Laura Reynolds SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. St. Petersburg, FL 33716 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-07 |
| Decision Date | 2011-06-22 |
| Summary: | summary |