The following data is part of a premarket notification filed by Medica-rents Co., Ltd. with the FDA for Prospera Pro-i, Pro-ii And Pro-iii Negative Pressure Wound Therapy System.
| Device ID | K112458 |
| 510k Number | K112458 |
| Device Name: | PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | MEDICA-RENTS CO., LTD. P.O. BOX 205 Derby, CT 06418 |
| Contact | Dina L Weissman, J.d. |
| Correspondent | Dina L Weissman, J.d. MEDICA-RENTS CO., LTD. P.O. BOX 205 Derby, CT 06418 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-26 |
| Decision Date | 2012-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50749756823864 | K112458 | 000 |
| 00749756390668 | K112458 | 000 |
| 00749756390675 | K112458 | 000 |
| 00749756390682 | K112458 | 000 |
| 00749756390699 | K112458 | 000 |
| 00749756390705 | K112458 | 000 |
| 50749756379408 | K112458 | 000 |
| 00749756379717 | K112458 | 000 |
| 50749756379736 | K112458 | 000 |
| 00749756907088 | K112458 | 000 |
| 50749756780150 | K112458 | 000 |
| 00749756781046 | K112458 | 000 |
| 00749756781053 | K112458 | 000 |
| 50749756787456 | K112458 | 000 |
| 00749756823289 | K112458 | 000 |
| 00749756823296 | K112458 | 000 |
| 00749756392457 | K112458 | 000 |