The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Bottle Decanter.
| Device ID | K852778 |
| 510k Number | K852778 |
| Device Name: | BOTTLE 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 | 1985-07-01 |
| Decision Date | 1985-08-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BOTTLE DECANTER 73610529 not registered Dead/Abandoned |
MEDI-PLAST INTERNATIONAL, INC. 1986-07-21 |