The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Wet Chamber.
Device ID | K020781 |
510k Number | K020781 |
Device Name: | WET CHAMBER |
Classification | Dressing, Wound, Occlusive |
Applicant | KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
Contact | Juith A Harbour |
Correspondent | Juith A Harbour KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
Product Code | NAD |
CFR Regulation Number | 878.4020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-11 |
Decision Date | 2002-05-06 |
Summary: | summary |