The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Transfer Device.
| Device ID | K853188 |
| 510k Number | K853188 |
| Device Name: | TRANSFER DEVICE |
| Classification | Set, I.v. Fluid Transfer |
| 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 | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-08-21 |