The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Endometrial Sampling Syringe.
| Device ID | K040189 |
| 510k Number | K040189 |
| Device Name: | ENDOMETRIAL SAMPLING SYRINGE |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| 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 | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-28 |
| Decision Date | 2004-10-04 |
| Summary: | summary |