The following data is part of a premarket notification filed by Medline with the FDA for Medline Excel Wheelchairs.
Device ID | K990463 |
510k Number | K990463 |
Device Name: | MEDLINE EXCEL WHEELCHAIRS |
Classification | Wheelchair, Mechanical |
Applicant | MEDLINE ONE MEDLINE PLACE Mundlelein, IL 60060 |
Contact | Lara N Simmons |
Correspondent | Lara N Simmons MEDLINE ONE MEDLINE PLACE Mundlelein, IL 60060 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-12 |
Decision Date | 1999-03-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884389830041 | K990463 | 000 |
10080196739592 | K990463 | 000 |
00080196132877 | K990463 | 000 |
00080196739588 | K990463 | 000 |
00080196739557 | K990463 | 000 |
00884389150774 | K990463 | 000 |
00193489001061 | K990463 | 000 |