The following data is part of a premarket notification filed by Poston & Cole Intl. with the FDA for Pci Custom Design Series.
Device ID | K861943 |
510k Number | K861943 |
Device Name: | PCI CUSTOM DESIGN SERIES |
Classification | Wheelchair, Special Grade |
Applicant | POSTON & COLE INTL. 2550 NINTH ST, STE 111 Berkeley, CA 94710 |
Contact | Rudy Bahr |
Correspondent | Rudy Bahr POSTON & COLE INTL. 2550 NINTH ST, STE 111 Berkeley, CA 94710 |
Product Code | IQC |
CFR Regulation Number | 890.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-20 |
Decision Date | 1986-05-30 |