The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec Decade Cuspidor.
Device ID | K903455 |
510k Number | K903455 |
Device Name: | A-DEC DECADE CUSPIDOR |
Classification | Unit, Operative Dental |
Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Contact | Pat Ridenour |
Correspondent | Pat Ridenour A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-31 |
Decision Date | 1990-10-24 |