SAUFLON MULTIPURPOSE SOLUTION - NO RUB— 510(k) K030278

Substantially Equivalent

Sauflon Pharmaceuticals, Ltd.

FDA 510(k) clearance K030278 for SAUFLON MULTIPURPOSE SOLUTION - NO RUB, Substantially Equivalent on 2003-07-30. Applicant: Sauflon Pharmaceuticals, Ltd.. Device class: 2.

Clearance details

Applicant
Sauflon Pharmaceuticals, Ltd.
Product code
Code LPN
Device class
Class 2
Regulation
21 CFR 886.5928
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Twickenham, Middlesex, GB
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LPN

product code LPN
Injury
333
Other
8
Total
341

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.