The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Genadyne A4-xlr8 Wound Vacuum System.
| Device ID | K090638 |
| 510k Number | K090638 |
| Device Name: | GENADYNE A4-XLR8 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-10 |
| Decision Date | 2009-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849405011200 | K090638 | 000 |