The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Kogan Endospeculum 9-1/2.
| Device ID | K842111 |
| 510k Number | K842111 |
| Device Name: | KOGAN ENDOSPECULUM 9-1/2 |
| Classification | Instrument, Cutting, Orthopedic |
| Applicant | J. SKLAR MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-29 |
| Decision Date | 1984-06-19 |