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 |