The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Genadyne Spiro Foam Dressing Kit.
| Device ID | K141961 |
| 510k Number | K141961 |
| Device Name: | GENADYNE SPIRO FOAM DRESSING KIT |
| 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 | 2014-07-18 |
| Decision Date | 2015-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849405031321 | K141961 | 000 |
| 00849405031314 | K141961 | 000 |
| 00849405021322 | K141961 | 000 |
| 00849405021315 | K141961 | 000 |