The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Xlr8 Plus (xlr8+).
| Device ID | K143726 |
| 510k Number | K143726 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849405011309 | K143726 | 000 |
| 00849405001454 | K143726 | 000 |
| 00849405000013 | K143726 | 000 |