The following data is part of a premarket notification filed by Anhui Tiankang Medical Technology Co.,ltd. with the FDA for Tk Insulin Syringe With/without Saftey Retractable Device.
Device ID | K191639 |
510k Number | K191639 |
Device Name: | TK Insulin Syringe With/without Saftey Retractable Device |
Classification | Syringe, Antistick |
Applicant | Anhui Tiankang Medical Technology Co.,Ltd. No.228 Weiyi Road, Economic Development Zone Tianchang, CN 239300 |
Contact | Bai Baodong |
Correspondent | Bai Baodong Anhui Tiankang Medical Technology Co.,Ltd. No.228 Weiyi Road, Economic Development Zone Tianchang, CN 239300 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-19 |
Decision Date | 2020-09-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00616784890524 | K191639 | 000 |
10812460024789 | K191639 | 000 |
10812460026240 | K191639 | 000 |
10812460026271 | K191639 | 000 |
10812460026295 | K191639 | 000 |
M99208012905S5 | K191639 | 000 |
00616784890128 | K191639 | 000 |
00616784890227 | K191639 | 000 |
00616784890326 | K191639 | 000 |
00616784890425 | K191639 | 000 |
10812460024772 | K191639 | 000 |