The following data is part of a premarket notification filed by China National Medicines & Health Prod. I/e Corp. with the FDA for Guo Guang Wheel Chair.
Device ID | K870043 |
510k Number | K870043 |
Device Name: | GUO GUANG WHEEL CHAIR |
Classification | Wheelchair, Mechanical |
Applicant | CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. 1000 THOMAS JEFFERSON ST. N.W. SUITE 500 Washington, DC 20007 |
Contact | Lisa Mitnick |
Correspondent | Lisa Mitnick CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. 1000 THOMAS JEFFERSON ST. N.W. SUITE 500 Washington, DC 20007 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-05 |
Decision Date | 1987-01-28 |