The following data is part of a premarket notification filed by Prime Engineering with the FDA for Granstand.
Device ID | K911608 |
510k Number | K911608 |
Device Name: | GRANSTAND |
Classification | Wheelchair, Standup |
Applicant | PRIME ENGINEERING 4838 W. JACQUELYN, SUITE 105 Fresno, CA 93722 |
Contact | Wilson Boegel |
Correspondent | Wilson Boegel PRIME ENGINEERING 4838 W. JACQUELYN, SUITE 105 Fresno, CA 93722 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-10 |
Decision Date | 1991-04-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GRANSTAND 74040046 1625847 Dead/Cancelled |
Axiom Industries, Inc. 1990-03-19 |