The following data is part of a premarket notification filed by Creo Quality, Llc. with the FDA for Npwt Wound Dressing Kit- Medium, Npwt Wound Dressing Kit- Large.
| Device ID | K132004 |
| 510k Number | K132004 |
| Device Name: | NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | CREO QUALITY, LLC. P.O. BOX 1784 Martinsville, IN 46151 |
| Contact | Jon Speer |
| Correspondent | Jon Speer CREO QUALITY, LLC. P.O. BOX 1784 Martinsville, IN 46151 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851675007227 | K132004 | 000 |
| 00851675007029 | K132004 | 000 |
| 00851675007036 | K132004 | 000 |
| 00851675007043 | K132004 | 000 |
| 00851675007050 | K132004 | 000 |
| 00851675007067 | K132004 | 000 |
| 00851675007074 | K132004 | 000 |
| 00851675007081 | K132004 | 000 |
| 00851675007128 | K132004 | 000 |
| 00851675007203 | K132004 | 000 |
| 00851675007210 | K132004 | 000 |
| 00851675007012 | K132004 | 000 |