K950337 is an FDA 510(k) clearance for the KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL. This device is classified as a Bur, Ear, Nose And Throat (Class I - General Controls, product code EQJ).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on August 23, 1995, 208 days after receiving the submission on January 27, 1995.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4140.
| 510(k) Number | K950337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1995 |
| Decision Date | August 23, 1995 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EQJ — Bur, Ear, Nose And Throat |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4140 |