The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet For Embryon Intrauter.
| Device ID | K980061 |
| 510k Number | K980061 |
| Device Name: | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | ROCKET MEDICAL PLC 1151 HOPE ST. Stamford, CT 06907 |
| Contact | R Keen |
| Correspondent | R Keen ROCKET MEDICAL PLC 1151 HOPE ST. Stamford, CT 06907 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-07 |
| Decision Date | 1998-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270957306 | K980061 | 000 |
| 05055270935892 | K980061 | 000 |
| 05055270935885 | K980061 | 000 |
| 05055270935878 | K980061 | 000 |
| 05055270956873 | K980061 | 000 |