HERSHMAN LENS FORCEPS W/OUT IRRIGATOR— 510(k) K770102

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K770102 for HERSHMAN LENS FORCEPS W/OUT IRRIGATOR, Substantially Equivalent on 1977-01-24. Applicant: Edward Weck, Inc.. Device class: 1.

Clearance details

Applicant
Edward Weck, Inc.
Product code
Code HNR
Device class
Class 1
Regulation
21 CFR 886.4350
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HNR

product code HNR
Malfunction
497
Other
1
Total
498

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 →

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