The following data is part of a premarket notification filed by Vipamat Technologie with the FDA for Hippocampe Wheelchair.
Device ID | K051709 |
510k Number | K051709 |
Device Name: | HIPPOCAMPE WHEELCHAIR |
Classification | Wheelchair, Special Grade |
Applicant | VIPAMAT TECHNOLOGIE 49 PLAIN STERRT North Attleboro, MA 02760 |
Contact | Mary Mcnamara-cullinane |
Correspondent | Mary Mcnamara-cullinane VIPAMAT TECHNOLOGIE 49 PLAIN STERRT North Attleboro, MA 02760 |
Product Code | IQC |
CFR Regulation Number | 890.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-27 |
Decision Date | 2005-08-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03664560000152 | K051709 | 000 |
03664560000176 | K051709 | 000 |
03664560000145 | K051709 | 000 |