The following data is part of a premarket notification filed by Den-tal-ez Mfg Co., Inc. with the FDA for Evacuator, Oral Cavity.
Device ID | K932824 |
510k Number | K932824 |
Device Name: | EVACUATOR, ORAL CAVITY |
Classification | Unit, Operative Dental |
Applicant | DEN-TAL-EZ MFG CO., INC. P.O. BOX 896 Valley Forge, PA 19482 |
Contact | Terence Snyder |
Correspondent | Terence Snyder DEN-TAL-EZ MFG CO., INC. P.O. BOX 896 Valley Forge, PA 19482 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-09 |
Decision Date | 1993-09-28 |