The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec 532/533 Delivery System Model, 532/533.
| Device ID | K032756 |
| 510k Number | K032756 |
| Device Name: | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 |
| Classification | Unit, Operative Dental |
| Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Contact | Tom Louisell |
| Correspondent | Tom Louisell 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 | 2003-09-05 |
| Decision Date | 2003-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10194665000103 | K032756 | 000 |
| 10194665006952 | K032756 | 000 |
| 10194665006969 | K032756 | 000 |
| 10194665006983 | K032756 | 000 |
| 10194665000592 | K032756 | 000 |
| 10194665000110 | K032756 | 000 |
| 10194665000134 | K032756 | 000 |
| 10194665000165 | K032756 | 000 |
| 10194665000004 | K032756 | 000 |
| 10194665000011 | K032756 | 000 |
| 10194665000028 | K032756 | 000 |
| 10194665000035 | K032756 | 000 |
| 10194665006976 | K032756 | 000 |