K983050 is an FDA 510(k) clearance for the PNEUMATIC CUTTER SYSTEM. This device is classified as a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II - Special Controls, product code ERL).
Submitted by Surgical Laser Technologies, Inc. (Montgomeryville, US). The FDA issued a Cleared decision on November 25, 1998, 85 days after receiving the submission on September 1, 1998.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4250.
| 510(k) Number | K983050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1998 |
| Decision Date | November 25, 1998 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4250 |