The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie Rigid Series.
Device ID | K973673 |
510k Number | K973673 |
Device Name: | QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES |
Classification | Wheelchair, Mechanical |
Applicant | SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
Contact | Rebecca Andersen |
Correspondent | Rebecca Andersen SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-26 |
Decision Date | 1997-11-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05022408045938 | K973673 | 000 |
00016958045932 | K973673 | 000 |
00016958043891 | K973673 | 000 |
00016958056006 | K973673 | 000 |
00016958099140 | K973673 | 000 |
00016958047349 | K973673 | 000 |
00016958057034 | K973673 | 000 |