The following data is part of a premarket notification filed by Chicago Assoc. For Retarded Citizens with the FDA for Hood, Operating, Surgical.
Device ID | K904969 |
510k Number | K904969 |
Device Name: | HOOD, OPERATING, SURGICAL |
Classification | Hood, Surgical |
Applicant | CHICAGO ASSOC. FOR RETARDED CITIZENS 8 SOUTH MICHIGAN AVE. Chicago, IL 60603 |
Contact | Mary Zubek |
Correspondent | Mary Zubek CHICAGO ASSOC. FOR RETARDED CITIZENS 8 SOUTH MICHIGAN AVE. Chicago, IL 60603 |
Product Code | FXY |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-05 |
Decision Date | 1990-12-12 |