The following data is part of a premarket notification filed by Medical Technology Research Inc. with the FDA for Mtr550 (tentative) Antimicrobial Silver Wound Gel.
| Device ID | K152519 |
| 510k Number | K152519 |
| Device Name: | MTR550 (Tentative) Antimicrobial Silver Wound Gel |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDICAL TECHNOLOGY RESEARCH INC. 2650 PROGRESS WAY Woodburn, OR 97071 |
| Contact | Bhalchandra M. Karandikar |
| Correspondent | Bhalchandra M. Karandikar MEDICAL TECHNOLOGY RESEARCH INC. 2650 PROGRESS WAY Woodburn, OR 97071 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-09-03 |
| Decision Date | 2016-06-02 |
| Summary: | summary |