The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Xlr8 Plus (xlr8+).
| Device ID | K141437 |
| 510k Number | K141437 |
| Device Name: | XLR8 PLUS (XLR8+) |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | GENADYNE BIOTECHNOLOGIES, INC. 16 MIDLAND AVE Hicksville, NY 11801 |
| Contact | Chien Ming, Goh |
| Correspondent | Chien Ming, Goh GENADYNE BIOTECHNOLOGIES, INC. 16 MIDLAND AVE Hicksville, NY 11801 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-30 |
| Decision Date | 2014-09-19 |
| Summary: | summary |