The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Board, Scooter.
Device ID | K781198 |
510k Number | K781198 |
Device Name: | BOARD, SCOOTER |
Classification | Board, Scooter, Prone |
Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNL |
CFR Regulation Number | 890.5370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-14 |
Decision Date | 1978-07-31 |