The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Holder For Mouth Stick.
Device ID | K823624 |
510k Number | K823624 |
Device Name: | HOLDER FOR MOUTH STICK |
Classification | System, Communication, Non-powered |
Applicant | FRED SAMMONS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ILP |
CFR Regulation Number | 890.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-06 |
Decision Date | 1982-12-30 |