The following data is part of a premarket notification filed by Burke Mobility Products with the FDA for Pace Saver Little Junior (modification).
Device ID | K954974 |
510k Number | K954974 |
Device Name: | PACE SAVER LITTLE JUNIOR (MODIFICATION) |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission, KS 66222 |
Contact | Duwayne Kramer |
Correspondent | Duwayne Kramer BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission, KS 66222 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-25 |
Decision Date | 1996-03-19 |