The following data is part of a premarket notification filed by Ms. Kate Teaney with the FDA for Electroglottograph Naked Egg Boxed Egg.
Device ID | K821079 |
510k Number | K821079 |
Device Name: | ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG |
Classification | Electroglottograph |
Applicant | MS. KATE TEANEY 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KLX |
CFR Regulation Number | 874.1325 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-19 |
Decision Date | 1982-05-10 |