The following data is part of a premarket notification filed by Grass-telefactor Product Group with the FDA for Beehive-64 Or Beehive-32, Digital Eeg Recording.
Device ID | K884937 |
510k Number | K884937 |
Device Name: | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING |
Classification | Heat Source For Bleaching Teeth |
Applicant | GRASS-TELEFACTOR PRODUCT GROUP UNION HILL BLDG., DEHAVEN ST. W. Conshohocken, PA 19428 |
Contact | John B Chatten |
Correspondent | John B Chatten GRASS-TELEFACTOR PRODUCT GROUP UNION HILL BLDG., DEHAVEN ST. W. Conshohocken, PA 19428 |
Product Code | EEG |
CFR Regulation Number | 872.6475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-28 |
Decision Date | 1989-04-14 |