The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec 7284 Cuspidor, Cascade.
Device ID | K925367 |
510k Number | K925367 |
Device Name: | A-DEC 7284 CUSPIDOR, CASCADE |
Classification | Unit, Suction Operatory |
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 | EBR |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-21 |
Decision Date | 1994-04-11 |