The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Vial Decanter.
Device ID | K852893 |
510k Number | K852893 |
Device Name: | VIAL DECANTER |
Classification | Container, I.v. |
Applicant | ADVANCE MEDICAL DESIGNS, INC. 1400 MARIETTA PARKWAY, SU 105 Marietta, GA 30067 |
Contact | Joseph R Cottone |
Correspondent | Joseph R Cottone ADVANCE MEDICAL DESIGNS, INC. 1400 MARIETTA PARKWAY, SU 105 Marietta, GA 30067 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-09 |
Decision Date | 1985-09-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VIAL DECANTER 73610692 not registered Dead/Abandoned |
MEDI-PLAST INTERNATIONAL, INC. 1986-07-21 |