The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for V.a.c. Abdominal Dressing.
| Device ID | K022011 |
| 510k Number | K022011 |
| Device Name: | V.A.C. ABDOMINAL DRESSING |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | KINETIC CONCEPTS, INC. 8023 VANTAGE DR. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
| Contact | Judith A Harbour |
| Correspondent | Judith A Harbour KINETIC CONCEPTS, INC. 8023 VANTAGE DR. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-19 |
| Decision Date | 2003-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00878237001325 | K022011 | 000 |
| 00849554002562 | K022011 | 000 |