K842111 is an FDA 510(k) clearance for the KOGAN ENDOSPECULUM 9-1/2. This device is classified as a Instrument, Cutting, Orthopedic (Class I - General Controls, product code HTZ).
Submitted by J. Sklar Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984, 21 days after receiving the submission on May 29, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K842111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1984 |
| Decision Date | June 19, 1984 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HTZ — Instrument, Cutting, Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |