The following data is part of a premarket notification filed by Pacific Dental Corp. with the FDA for Spaceline High Volume Evacuation Handpie.
| Device ID | K801682 |
| 510k Number | K801682 |
| Device Name: | SPACELINE HIGH VOLUME EVACUATION HANDPIE |
| Classification | Evacuator, Oral Cavity |
| Applicant | PACIFIC DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHZ |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-21 |
| Decision Date | 1980-08-04 |