The following data is part of a premarket notification filed by Nieusma R & D, Inc. with the FDA for Dental Sani-sleeve Sterile 100mm X 2200mm #1102.
| Device ID | K892882 |
| 510k Number | K892882 |
| Device Name: | DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 |
| Classification | Evacuator, Oral Cavity |
| Applicant | NIEUSMA R & D, INC. 13658 HANFORD COURT Warren, MI 48093 |
| Contact | Nieusma, Jr |
| Correspondent | Nieusma, Jr NIEUSMA R & D, INC. 13658 HANFORD COURT Warren, MI 48093 |
| Product Code | EHZ |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-06 |
| Decision Date | 1989-06-23 |