The following data is part of a premarket notification filed by Argentum Medical, Llc with the FDA for Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy Ag Antimicrobial Wound Contact Negativ.
| Device ID | K141033 |
| 510k Number | K141033 |
| Device Name: | SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | ARGENTUM MEDICAL, LLC 2571 KANEVILLE COURT Geneva, IL 60134 |
| Contact | C. Richard Foster |
| Correspondent | C. Richard Foster ARGENTUM MEDICAL, LLC 2571 KANEVILLE COURT Geneva, IL 60134 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-04-22 |
| Decision Date | 2014-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857278000849 | K141033 | 000 |
| 10857278000129 | K141033 | 000 |
| 10857278000136 | K141033 | 000 |
| 00857278000146 | K141033 | 000 |
| 00857278000153 | K141033 | 000 |
| 00857278000160 | K141033 | 000 |
| 10857278000174 | K141033 | 000 |
| 10857278000181 | K141033 | 000 |
| 20857278000621 | K141033 | 000 |
| 10857278000808 | K141033 | 000 |
| 10857278000815 | K141033 | 000 |
| 10857278000822 | K141033 | 000 |
| 10857278000839 | K141033 | 000 |
| 00857278000115 | K141033 | 000 |