The following data is part of a premarket notification filed by Cimed Intl., Inc. with the FDA for Janacek Tubo-uterine Implantation Set.
| Device ID | K840766 |
| 510k Number | K840766 |
| Device Name: | JANACEK TUBO-UTERINE IMPLANTATION SET |
| Classification | Forceps |
| Applicant | CIMED INTL., INC. C/O MYRON E. SILDON ASSOCIATES 2800 CITY CTR SQ./1100 MAIN ST Kansas City , MO 64105 - |
| Contact | James L Kenworthy |
| Correspondent | James L Kenworthy CIMED INTL., INC. C/O MYRON E. SILDON ASSOCIATES 2800 CITY CTR SQ./1100 MAIN ST Kansas City , MO 64105 - |
| Product Code | HTD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-04-23 |