The following data is part of a premarket notification filed by Athena Technology, Inc. with the FDA for Athena 20r S Type Slow Speed Handpiece Motor.
Device ID | K974671 |
510k Number | K974671 |
Device Name: | ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR |
Classification | Handpiece, Air-powered, Dental |
Applicant | ATHENA TECHNOLOGY, INC. 984 NORTH AMELIA AVE. San Dimas, CA 91773 |
Contact | William T Anderson |
Correspondent | William T Anderson ATHENA TECHNOLOGY, INC. 984 NORTH AMELIA AVE. San Dimas, CA 91773 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-15 |
Decision Date | 1998-03-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10302737530032 | K974671 | 000 |
10302730001928 | K974671 | 000 |
10302730002000 | K974671 | 000 |
10302730002017 | K974671 | 000 |
10302732952495 | K974671 | 000 |
10302734100016 | K974671 | 000 |
10302737500011 | K974671 | 000 |
10302737500035 | K974671 | 000 |
10302737510010 | K974671 | 000 |
10302737510034 | K974671 | 000 |
10302737520019 | K974671 | 000 |
10302737520033 | K974671 | 000 |
10302730001911 | K974671 | 000 |