The following data is part of a premarket notification filed by Dci Intl. with the FDA for Dental Operative Unit Accesories.
Device ID | K944271 |
510k Number | K944271 |
Device Name: | DENTAL OPERATIVE UNIT ACCESORIES |
Classification | Unit, Operative Dental |
Applicant | DCI INTL. PO BOX 228 Newberg, OR 97132 -0228 |
Contact | David R Cole |
Correspondent | David R Cole DCI INTL. PO BOX 228 Newberg, OR 97132 -0228 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-30 |
Decision Date | 1994-12-29 |