PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE— 510(k) K141638

Name: FDA 510(k) clearance K141638
Creator: U.S. Food and Drug Administration
Published: 2014-09-17

Substantially Equivalent

Propper Manufacturing Co., Inc.

FDA 510(k) clearance K141638 for PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE, Substantially Equivalent on 2014-09-17. Applicant: Propper Manufacturing Co., Inc.. Device class: 2.

Clearance details

Applicant: Propper Manufacturing Co., Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2014-06-19
Decision date: 2014-09-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Long Island, NY, US

Download summary PDF View on FDA.gov ↗

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