The following data is part of a premarket notification filed by General Components Intl., Inc. with the FDA for Zero Gravity Wheelchair Components, Modification.
Device ID | K933051 |
510k Number | K933051 |
Device Name: | ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION |
Classification | Components, Wheelchair |
Applicant | GENERAL COMPONENTS INTL., INC. 363 W. 2720 SOUTH, SUITE B Salt Lake City, UT 84115 |
Contact | Tony M Pearce |
Correspondent | Tony M Pearce GENERAL COMPONENTS INTL., INC. 363 W. 2720 SOUTH, SUITE B Salt Lake City, UT 84115 |
Product Code | KNN |
CFR Regulation Number | 890.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-25 |
Decision Date | 1993-10-12 |