The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Genadyne A4 Wound Vacuum System.
| Device ID | K082676 |
| 510k Number | K082676 |
| Device Name: | GENADYNE A4 WOUND VACUUM SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | GENADYNE BIOTECHNOLOGIES, INC. 65 WATERMILL LANE Great Neck, NY 11021 |
| Contact | Chien-ming Goh |
| Correspondent | Chien-ming Goh GENADYNE BIOTECHNOLOGIES, INC. 65 WATERMILL LANE Great Neck, NY 11021 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2008-12-18 |
| Summary: | summary |