The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Madayag, Manghini, Franseen, Green, Trocar Needles.
| Device ID | K895457 |
| 510k Number | K895457 |
| Device Name: | MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES |
| Classification | Instrument, Biopsy |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-05 |
| Decision Date | 1989-11-01 |