The following data is part of a premarket notification filed by R82 A/s with the FDA for Rabbit Mobile Standing Frame.
Device ID | K030882 |
510k Number | K030882 |
Device Name: | RABBIT MOBILE STANDING FRAME |
Classification | Wheelchair, Standup |
Applicant | R82 A/S 12801 EAST INDEPENDENCE BLVD. Stallings, NC 28105 |
Contact | Kirk L Mackenzie |
Correspondent | Kirk L Mackenzie R82 A/S 12801 EAST INDEPENDENCE BLVD. Stallings, NC 28105 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-20 |
Decision Date | 2003-04-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05707292436030 | K030882 | 000 |
05707292422156 | K030882 | 000 |
05707292422163 | K030882 | 000 |
05707292422170 | K030882 | 000 |
05707292422187 | K030882 | 000 |
05707292422606 | K030882 | 000 |
05707292422613 | K030882 | 000 |
05707292422620 | K030882 | 000 |
05707292422637 | K030882 | 000 |
05707292422835 | K030882 | 000 |
05707292422842 | K030882 | 000 |
05707292130006 | K030882 | 000 |