The following data is part of a premarket notification filed by Global Medi Products with the FDA for Global Medi Products Retractable Safety Syringe.
Device ID | K120641 |
510k Number | K120641 |
Device Name: | GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE |
Classification | Syringe, Antistick |
Applicant | GLOBAL MEDI PRODUCTS 1083 DELWARE AVE. Buffalo, NY 14209 |
Contact | Robert O Dean |
Correspondent | Robert O Dean GLOBAL MEDI PRODUCTS 1083 DELWARE AVE. Buffalo, NY 14209 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-03-02 |
Decision Date | 2012-10-17 |
Summary: | summary |