The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for V.a.c. Dermatac Drape.
Device ID | K181505 |
510k Number | K181505 |
Device Name: | V.A.C. DERMATAC Drape |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 |
Contact | Melanie Avila |
Correspondent | Melanie Avila KCI USA, Inc. 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 | 2018-06-07 |
Decision Date | 2019-03-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20849554007202 | K181505 | 000 |
20849554007196 | K181505 | 000 |
20849554007189 | K181505 | 000 |
00849554005198 | K181505 | 000 |