PHARMASEAL STERILE WOUND CARE DRESSING— 510(k) K884397
Substantially Equivalent for Some IndicationsBaxter Healthcare Corp
FDA 510(k) clearance K884397 for PHARMASEAL STERILE WOUND CARE DRESSING, Substantially Equivalent for Some Indications on 1988-12-27. Applicant: Baxter Healthcare Corp. Device class: Unclassified.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Valencia, CA, US
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Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.