The following data is part of a premarket notification filed by Ssi Medical Services, Inc. with the FDA for Supercair.
Device ID | K890523 |
510k Number | K890523 |
Device Name: | SUPERCAIR |
Classification | Bed, Air Fluidized |
Applicant | SSI MEDICAL SERVICES, INC. BURDITT RADZIUS CHARTERED 333 W.WACKER DR.SUITE 2600 Chicago, IL 60606 |
Contact | A Marcouiller |
Correspondent | A Marcouiller SSI MEDICAL SERVICES, INC. BURDITT RADZIUS CHARTERED 333 W.WACKER DR.SUITE 2600 Chicago, IL 60606 |
Product Code | INX |
CFR Regulation Number | 890.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-02 |
Decision Date | 1989-02-10 |