URAM OPHTHALMIC LASER ENDOSCOPE— 510(k) K910532

Substantially Equivalent

Martin S. Knopf Assoc., Inc.

FDA 510(k) clearance K910532 for URAM OPHTHALMIC LASER ENDOSCOPE, Substantially Equivalent on 1991-05-28. Applicant: Martin S. Knopf Assoc., Inc.. Device class: 2.

Clearance details

Applicant
Martin S. Knopf Assoc., Inc.
Product code
Code HQF
Device class
Class 2
Regulation
21 CFR 886.4390
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlboro, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HQF

product code HQF
Injury
166
Other
1
Total
167

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.