PHYTACARE ALGINATE HYDROGEL WOUND DRESSING— 510(k) K980132

Substantially Equivalent for Some Indications

Phytatek Laboratories, Inc.

FDA 510(k) clearance K980132 for PHYTACARE ALGINATE HYDROGEL WOUND DRESSING, Substantially Equivalent for Some Indications on 1998-06-26. Applicant: Phytatek Laboratories, Inc..

Clearance details

Applicant: Phytatek Laboratories, Inc.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1998-01-15
Decision date: 1998-06-26
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.