The following data is part of a premarket notification filed by Sincere Medical Device Co., Ltd. with the FDA for 3s Safety Syringe With/without Needle.
Device ID | K142435 |
510k Number | K142435 |
Device Name: | 3S Safety Syringe With/without Needle |
Classification | Syringe, Antistick |
Applicant | Sincere Medical Device Co., Ltd. Rm 218, 2F., No.183, Zhouzi St. Taipei, TW 114 |
Contact | Garfield Wang |
Correspondent | Garfield Wang Sincere Medical Device Co., Ltd. Rm 218, 2F., No.183, Zhouzi St. Taipei, TW 114 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-29 |
Decision Date | 2015-02-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
G018SY03LL0214 | K142435 | 000 |
G018SY01LL0212 | K142435 | 000 |