The following data is part of a premarket notification filed by Burke, Inc. with the FDA for Pace Saver, Little Junior (modification)(motorized Three-wheeled Vehicle).
| Device ID | K965123 |
| 510k Number | K965123 |
| Device Name: | PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | BURKE, INC. 1800 MERRIAM LN. Kansas City, KS 66106 |
| Contact | Duwayne E Kramer |
| Correspondent | Duwayne E Kramer BURKE, INC. 1800 MERRIAM LN. Kansas City, KS 66106 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-15 |
| Decision Date | 1997-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B314150871 | K965123 | 000 |
| B314150571 | K965123 | 000 |
| B314150631 | K965123 | 000 |
| B314150671 | K965123 | 000 |
| B314150681 | K965123 | 000 |
| B314150701 | K965123 | 000 |
| B314150721 | K965123 | 000 |
| B314150731 | K965123 | 000 |
| B314150831 | K965123 | 000 |
| B314150861 | K965123 | 000 |
| B314150351 | K965123 | 000 |