The following data is part of a premarket notification filed by Cincinnati Sub-zero Products, Inc. with the FDA for Warmair System.
Device ID | K910327 |
510k Number | K910327 |
Device Name: | WARMAIR SYSTEM |
Classification | System, Thermal Regulating |
Applicant | CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. Cincinnati, OH 45241 |
Contact | Douglas Clark |
Correspondent | Douglas Clark CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. Cincinnati, OH 45241 |
Product Code | DWJ |
CFR Regulation Number | 870.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-25 |
Decision Date | 1991-05-16 |