The following data is part of a premarket notification filed by Jiangsu Suyun Medical Materials Co., Ltd. with the FDA for Disposable Endometrial Suction Curette.
| Device ID | K102847 |
| 510k Number | K102847 |
| Device Name: | DISPOSABLE ENDOMETRIAL SUCTION CURETTE |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | JIANGSU SUYUN MEDICAL MATERIALS CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong JIANGSU SUYUN MEDICAL MATERIALS CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20612479202140 | K102847 | 000 |