The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Delivery Pump For Sterile Irrigant & Handpiece Dr..
| Device ID | K882526 |
| 510k Number | K882526 |
| Device Name: | DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR. |
| Classification | Unit, Operative Dental |
| Applicant | ASEPTICO, INC. P.O. BOX 3209 Kirkland, WA 98083 |
| Contact | Douglas H Kazen |
| Correspondent | Douglas H Kazen ASEPTICO, INC. P.O. BOX 3209 Kirkland, WA 98083 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-31 |
| Decision Date | 1988-12-08 |