The following data is part of a premarket notification filed by Sub-q, Inc. with the FDA for Irrigation Syringe Kit.
| Device ID | K982435 |
| 510k Number | K982435 |
| Device Name: | IRRIGATION SYRINGE KIT |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | SUB-Q, INC. 1062-D CALLE NEGOCIO San Clemente, CA 92673 |
| Contact | Vaughan P Whalen |
| Correspondent | Vaughan P Whalen SUB-Q, INC. 1062-D CALLE NEGOCIO San Clemente, CA 92673 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1998-11-06 |