The following data is part of a premarket notification filed by Medical Composite Technology, Inc. with the FDA for Srx Comp Ultralight Wheelchair.
Device ID | K932927 |
510k Number | K932927 |
Device Name: | SRX COMP ULTRALIGHT WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | MEDICAL COMPOSITE TECHNOLOGY, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
Contact | John F Lemker |
Correspondent | John F Lemker MEDICAL COMPOSITE TECHNOLOGY, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-15 |
Decision Date | 1993-07-22 |