The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc with the FDA for Xlr8 White Foam Dressing Kit And Xlr8 White Foam Small Dressing Kit And.
| Device ID | K142646 |
| 510k Number | K142646 |
| Device Name: | XLR8 White Foam Dressing Kit And XLR8 White Foam Small Dressing Kit And |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Genadyne Biotechnologies, Inc 16 Midland Ave Hicksville, NY 11801 |
| Contact | Chien Ming |
| Correspondent | Chien Ming 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 | 2014-09-17 |
| Decision Date | 2015-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849405035138 | K142646 | 000 |
| 00849405035121 | K142646 | 000 |
| 00849405035114 | K142646 | 000 |
| 00849405025139 | K142646 | 000 |
| 00849405025122 | K142646 | 000 |
| 00849405025115 | K142646 | 000 |