The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Quickie Tsr.
Device ID | K952641 |
510k Number | K952641 |
Device Name: | QUICKIE TSR |
Classification | Wheelchair, Mechanical |
Applicant | SUNRISE MEDICAL, INC. 2842 BUSINESS PARK AVE. Fresno, CA 93727 |
Contact | Douglas Munsey |
Correspondent | Douglas Munsey SUNRISE MEDICAL, INC. 2842 BUSINESS PARK AVE. Fresno, CA 93727 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-09 |
Decision Date | 1995-07-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00016958053661 | K952641 | 000 |