The following data is part of a premarket notification filed by Polymint Industrial Co. Ltd. with the FDA for Mitrasheer Transplant Dressing.
| Device ID | K911649 |
| 510k Number | K911649 |
| Device Name: | MITRASHEER TRANSPLANT DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | POLYMINT INDUSTRIAL CO. LTD. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Andrew M Reed |
| Correspondent | Andrew M Reed POLYMINT INDUSTRIAL CO. LTD. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-08-07 |