The following data is part of a premarket notification filed by Bantex Corp. with the FDA for Bantex Brand Wheelchairs.
Device ID | K915262 |
510k Number | K915262 |
Device Name: | BANTEX BRAND WHEELCHAIRS |
Classification | Wheelchair, Mechanical |
Applicant | BANTEX CORP. P.O. BOX 4098 Burlingame, CA 94011 |
Contact | Owen Lin |
Correspondent | Owen Lin BANTEX CORP. P.O. BOX 4098 Burlingame, CA 94011 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-19 |
Decision Date | 1992-01-13 |