The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Annelid.
Device ID | K940886 |
510k Number | K940886 |
Device Name: | ANNELID |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
Applicant | KINETIC CONCEPTS, INC. 3440 EAST HOUSTON ST. San Antonio, TX 78219 |
Contact | William H Quirk |
Correspondent | William H Quirk KINETIC CONCEPTS, INC. 3440 EAST HOUSTON ST. San Antonio, TX 78219 |
Product Code | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-25 |
Decision Date | 1994-11-17 |