The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Vacuum Assisted Closure.
Device ID | K021500 |
510k Number | K021500 |
Device Name: | VACUUM ASSISTED CLOSURE |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
Contact | William H Quirk |
Correspondent | William H Quirk KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-09 |
Decision Date | 2002-12-20 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VACUUM ASSISTED CLOSURE 76179849 not registered Dead/Abandoned |
Kinetic Concepts, Inc. 2000-12-12 |
VACUUM ASSISTED CLOSURE 75874141 2657666 Live/Registered |
KCI Licensing, Inc. 1999-12-15 |