The following data is part of a premarket notification filed by Nieusma R & D, Inc. with the FDA for Sani-sleeve Drape For Dental Use.
| Device ID | K885299 |
| 510k Number | K885299 |
| Device Name: | SANI-SLEEVE DRAPE FOR DENTAL USE |
| Classification | Unit, Operative Dental |
| 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 | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-27 |
| Decision Date | 1989-03-16 |