The following data is part of a premarket notification filed by Den-tal-ez Mfg Co., Inc. with the FDA for Autochuck Attachment.
Device ID | K874294 |
510k Number | K874294 |
Device Name: | AUTOCHUCK ATTACHMENT |
Classification | Handpiece, Air-powered, Dental |
Applicant | DEN-TAL-EZ MFG CO., INC. P.O. BOX 896 Valley Forge, PA 19482 |
Contact | Horace Wilmer |
Correspondent | Horace Wilmer DEN-TAL-EZ MFG CO., INC. P.O. BOX 896 Valley Forge, PA 19482 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-20 |
Decision Date | 1987-12-29 |