The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for A4-xlr8 Foam Dressing.
| Device ID | K092992 |
| 510k Number | K092992 |
| Device Name: | A4-XLR8 FOAM DRESSING |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | GENADYNE BIOTECHNOLOGIES, INC. 1468 Harwell Avenue Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith GENADYNE BIOTECHNOLOGIES, INC. 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2010-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849405033103 | K092992 | 000 |
| 00849405021124 | K092992 | 000 |
| 00849405021131 | K092992 | 000 |
| 00849405021216 | K092992 | 000 |
| 00849405021223 | K092992 | 000 |
| 00849405021230 | K092992 | 000 |
| 00849405021247 | K092992 | 000 |
| 00849405023104 | K092992 | 000 |
| 00849405031116 | K092992 | 000 |
| 00849405031123 | K092992 | 000 |
| 00849405031130 | K092992 | 000 |
| 00849405031147 | K092992 | 000 |
| 00849405031215 | K092992 | 000 |
| 00849405031222 | K092992 | 000 |
| 00849405031239 | K092992 | 000 |
| 00849405021117 | K092992 | 000 |