The following data is part of a premarket notification filed by Canadian Posture And Seating Centre, Inc. with the FDA for Personal Back With Fip Kit.
Device ID | K894770 |
510k Number | K894770 |
Device Name: | PERSONAL BACK WITH FIP KIT |
Classification | Components, Wheelchair |
Applicant | CANADIAN POSTURE AND SEATING CENTRE, INC. 15 HOWARD PLACE, P.O. BOX 1473 STATION C, KITCHENER, ONTARIO Canada N2g 4p2, CA |
Contact | Mundy. P Eng. |
Correspondent | Mundy. P Eng. CANADIAN POSTURE AND SEATING CENTRE, INC. 15 HOWARD PLACE, P.O. BOX 1473 STATION C, KITCHENER, ONTARIO Canada N2g 4p2, CA |
Product Code | KNN |
CFR Regulation Number | 890.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-26 |
Decision Date | 1989-09-11 |