MITRASHEER TRANSPLANT DRESSING— 510(k) K911649

Name: FDA 510(k) clearance K911649
Creator: U.S. Food and Drug Administration
Published: 1991-08-07

Substantially Equivalent

Polymint Industrial Co. , Ltd.

FDA 510(k) clearance K911649 for MITRASHEER TRANSPLANT DRESSING, Substantially Equivalent on 1991-08-07. Applicant: Polymint Industrial Co. , Ltd.. Device class: Unclassified.

Clearance details

Applicant: Polymint Industrial Co. , Ltd.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1991-04-12
Decision date: 1991-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Polymint Industrial Co. , Ltd.

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K932457 — SPYROGEL WOUND DRESSING1994-02-09
K931634 — VARIOUS KITS1993-11-30
K921775 — SPYROFLEX WOUND CLOSURES1992-05-19
K891644 — SAMBORD LATEX PATIENT EXAMINATION GLOVES1989-06-19

Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.