The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Adult Perceptual Motor Puzzles (5331-01).
Device ID | K880647 |
510k Number | K880647 |
Device Name: | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) |
Classification | Chart, Visual Acuity |
Applicant | FRED SAMMONS, INC. 145 TOWER DR. Burr Ridge, IL 60521 |
Contact | Susan Bledsoe |
Correspondent | Susan Bledsoe FRED SAMMONS, INC. 145 TOWER DR. Burr Ridge, IL 60521 |
Product Code | HOX |
CFR Regulation Number | 886.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-16 |
Decision Date | 1988-04-01 |