The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Quickie G Series, Model G-424.
Device ID | K983677 |
510k Number | K983677 |
Device Name: | QUICKIE G SERIES, MODEL G-424 |
Classification | Wheelchair, Powered |
Applicant | SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
Contact | Rebecca Anderson |
Correspondent | Rebecca Anderson SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-19 |
Decision Date | 1998-11-06 |
Summary: | summary |