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 |