The following data is part of a premarket notification filed by Seldoren Ltd. with the FDA for Vac - Rite Right Angle Aspirator Tube & Holder.
| Device ID | K864621 |
| 510k Number | K864621 |
| Device Name: | VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER |
| Classification | Evacuator, Oral Cavity |
| Applicant | SELDOREN LTD. INTERNATIONAL MARKETING CONS. 230 PARK AVENUE, SUITE 917 New York, NY 10136 |
| Contact | Derek Rawden |
| Correspondent | Derek Rawden SELDOREN LTD. INTERNATIONAL MARKETING CONS. 230 PARK AVENUE, SUITE 917 New York, NY 10136 |
| Product Code | EHZ |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-24 |
| Decision Date | 1987-02-13 |