The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Soft Catcher's Mitt.
Device ID | K823656 |
510k Number | K823656 |
Device Name: | SOFT CATCHER'S MITT |
Classification | Adaptor, Recreational |
Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILT |
CFR Regulation Number | 890.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-06 |
Decision Date | 1983-01-21 |