SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED— 510(k) K964398
Substantially EquivalentPolymedica Industries, Inc.
FDA 510(k) clearance K964398 for SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED, Substantially Equivalent on 1997-10-24. Applicant: Polymedica Industries, Inc..
Clearance details
- Applicant
- Polymedica Industries, Inc.
- Product code
- Code MGP
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Golden,, CO, US
Adverse events under product code MGP
product code MGP- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.