The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec Dental Light.
Device ID | K893044 |
510k Number | K893044 |
Device Name: | A-DEC DENTAL LIGHT |
Classification | Light, Operating, Dental |
Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Contact | John Lewis |
Correspondent | John Lewis A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Product Code | EAZ |
CFR Regulation Number | 872.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-24 |
Decision Date | 1989-07-14 |