The following data is part of a premarket notification filed by 3m Health Care Business Group with the FDA for Prevena Restor Adapti-form Incision Management System (pre6001); Prevena Restor Adapti-form Dressing (pre6055).
| Device ID | K220660 |
| 510k Number | K220660 |
| Device Name: | Prevena Restor Adapti-Form Incision Management System (PRE6001); Prevena Restor Adapti-Form Dressing (PRE6055) |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | 3M Health Care Business Group 6203 Farinon Dr. San Antonio, TX 78249 |
| Contact | Teri Feeley |
| Correspondent | Teri Feeley 3M Health Care Business Group 6203 Farinon Dr. San Antonio, TX 78249 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554008373 | K220660 | 000 |
| 00849554008014 | K220660 | 000 |