The following data is part of a premarket notification filed by Perfect Medical Industry Co., Ltd. with the FDA for Perfect Safety Syringe.
Device ID | K030604 |
510k Number | K030604 |
Device Name: | PERFECT SAFETY SYRINGE |
Classification | Syringe, Antistick |
Applicant | PERFECT MEDICAL INDUSTRY CO., LTD. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
Contact | Eric Luo |
Correspondent | Eric Luo PERFECT MEDICAL INDUSTRY CO., LTD. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-25 |
Decision Date | 2004-04-30 |