The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Disposable Vacuum Curettes.
| Device ID | K161106 |
| 510k Number | K161106 |
| Device Name: | PANPAC DISPOSABLE VACUUM CURETTES |
| Classification | Cannula, Suction, Uterine |
| Applicant | PANPAC MEDICAL CORPORATION 6F-1,2, NO. 202, SEC.3, TA-TONG ROAD Shi-chih Dist., TW 22103 |
| Contact | Yen-ming Pan |
| Correspondent | Yen-ming Pan PANPAC MEDICAL CORPORATION 6F-1,2, NO. 202, SEC.3, TA-TONG ROAD Shi-chih Dist., TW 22103 |
| Product Code | HGH |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-19 |
| Decision Date | 2017-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04715309125403 | K161106 | 000 |
| 04715309125281 | K161106 | 000 |
| 04715309125274 | K161106 | 000 |
| 04713025223953 | K161106 | 000 |
| 04713025223946 | K161106 | 000 |
| 04713025223939 | K161106 | 000 |
| 04713025223922 | K161106 | 000 |
| 04713025223915 | K161106 | 000 |
| 04713025223908 | K161106 | 000 |
| 04713025223892 | K161106 | 000 |
| 04715309125298 | K161106 | 000 |
| 04715309125304 | K161106 | 000 |
| 04715309125397 | K161106 | 000 |
| 04715309125380 | K161106 | 000 |
| 04715309125373 | K161106 | 000 |
| 04715309125366 | K161106 | 000 |
| 04715309125359 | K161106 | 000 |
| 04715309125342 | K161106 | 000 |
| 04715309125335 | K161106 | 000 |
| 04715309125328 | K161106 | 000 |
| 04715309124796 | K161106 | 000 |
| 04713025223885 | K161106 | 000 |