The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Renasys-g Gauze Dressing Kits With Soft Port.
| Device ID | K162129 |
| 510k Number | K162129 |
| Device Name: | RENASYS-G Gauze Dressing Kits With Soft Port |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 300 St Petersburg, FL 33716 |
| Contact | Laura Reynolds |
| Correspondent | Laura Reynolds Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 300 St Petersburg, FL 33716 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-08-01 |
| Decision Date | 2016-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30040565127225 | K162129 | 000 |
| 30040565127218 | K162129 | 000 |
| 30040565127201 | K162129 | 000 |
| 30040565127195 | K162129 | 000 |
| 30040565125740 | K162129 | 000 |
| 30040565125733 | K162129 | 000 |
| 30040565125726 | K162129 | 000 |
| 30040565125719 | K162129 | 000 |