The following data is part of a premarket notification filed by 3m with the FDA for Dermatac Drape.
Device ID | K220560 |
510k Number | K220560 |
Device Name: | Dermatac Drape |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | 3M 6203 Farinon Drive San Antonio, TX 78249 |
Contact | Melanie Avila |
Correspondent | Melanie Avila 3M 6203 Farinon Drive 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 | 2022-02-28 |
Decision Date | 2022-07-14 |