The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Cowboy Iii.
Device ID | K932215 |
510k Number | K932215 |
Device Name: | COWBOY III |
Classification | Sleeve, Limb, Compressible |
Applicant | KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
Contact | William Quirk |
Correspondent | William Quirk KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-07 |
Decision Date | 1993-07-21 |