The following data is part of a premarket notification filed by Crow River Industries, Inc. with the FDA for Vangator Ii.
Device ID | K952946 |
510k Number | K952946 |
Device Name: | VANGATOR II |
Classification | Elevator, Wheelchair, Portable |
Applicant | CROW RIVER INDUSTRIES, INC. 14800 28TH AVENUE NORTH Minneapollis, MN 55447 |
Contact | Robert C Samec |
Correspondent | Robert C Samec CROW RIVER INDUSTRIES, INC. 14800 28TH AVENUE NORTH Minneapollis, MN 55447 |
Product Code | ING |
CFR Regulation Number | 890.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-26 |
Decision Date | 1995-11-29 |