The following data is part of a premarket notification filed by Pin Dot Products, Inc. with the FDA for Impala Wheels.
Device ID | K913509 |
510k Number | K913509 |
Device Name: | IMPALA WHEELS |
Classification | Components, Wheelchair |
Applicant | PIN DOT PRODUCTS, INC. 6001 GROSS POINT RD. Niles, IL 60648 -4027 |
Product Code | KNN |
CFR Regulation Number | 890.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-07 |
Decision Date | 1991-09-05 |