K800669 is an FDA 510(k) clearance for the FELDMAN MINI-SAW, #300000. This device is classified as a Saw, Surgical, Ent (electric Or Pneumatic) (Class I - General Controls, product code EWQ).
Submitted by KARL STORZ Endoscopy-America, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1980, 26 days after receiving the submission on March 26, 1980.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K800669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1980 |
| Decision Date | April 21, 1980 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EWQ — Saw, Surgical, Ent (electric Or Pneumatic) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |