The following data is part of a premarket notification filed by Athena Technology, Inc. with the FDA for Athena High Speed Handpiece.
Device ID | K925678 |
510k Number | K925678 |
Device Name: | ATHENA HIGH SPEED HANDPIECE |
Classification | Handpiece, Air-powered, Dental |
Applicant | ATHENA TECHNOLOGY, INC. 420 S. VERMONT AVE. Glendora, CA 91740 |
Contact | William T Anderson |
Correspondent | William T Anderson ATHENA TECHNOLOGY, INC. 420 S. VERMONT AVE. Glendora, CA 91740 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-10 |
Decision Date | 1994-12-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10302730001997 | K925678 | 000 |
10302730001980 | K925678 | 000 |
10302730001942 | K925678 | 000 |
10302730000457 | K925678 | 000 |