The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for Dental Syringe Tip.
| Device ID | K931137 |
| 510k Number | K931137 |
| Device Name: | DENTAL SYRINGE TIP |
| Classification | Unit, Syringe, Air And/or Water |
| Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Contact | Mat Parlier |
| Correspondent | Mat Parlier A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Product Code | ECB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-05 |
| Decision Date | 1993-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20194665001978 | K931137 | 000 |
| 10194665002091 | K931137 | 000 |
| 10194665002060 | K931137 | 000 |