K892882 is an FDA 510(k) clearance for the DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102. This device is classified as a Evacuator, Oral Cavity (Class I - General Controls, product code EHZ).
Submitted by Nieusma R & D, Inc. (Warren, US). The FDA issued a Cleared decision on June 23, 1989, 78 days after receiving the submission on April 6, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K892882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1989 |
| Decision Date | June 23, 1989 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EHZ — Evacuator, Oral Cavity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |