The following data is part of a premarket notification filed by Suzric Enterprise Co., Ltd. with the FDA for Voltera Powered Suction Pump.
| Device ID | K112853 |
| 510k Number | K112853 |
| Device Name: | VOLTERA POWERED SUCTION PUMP |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | SUZRIC ENTERPRISE CO., LTD. NO. 77, KEJI 2ST ROAD GUISHAN TOWNSHIP Taoyuan County, TW 333 |
| Contact | Michael Lee |
| Correspondent | Michael Lee SUZRIC ENTERPRISE CO., LTD. NO. 77, KEJI 2ST ROAD GUISHAN TOWNSHIP Taoyuan County, TW 333 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-29 |
| Decision Date | 2012-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04713616092982 | K112853 | 000 |
| 04913616090308 | K112853 | 000 |
| 04713616090292 | K112853 | 000 |
| 04713616090261 | K112853 | 000 |
| 04713616090094 | K112853 | 000 |
| 04713616090278 | K112853 | 000 |
| 04713616090087 | K112853 | 000 |
| 04713616090841 | K112853 | 000 |
| 04713616090209 | K112853 | 000 |