OPHTEC ENCLAVATION NEEDLE

Hook, Ophthalmic

OPHTEC USA

The following data is part of a premarket notification filed by Ophtec Usa with the FDA for Ophtec Enclavation Needle.

Pre-market Notification Details

Device IDK030471
510k NumberK030471
Device Name:OPHTEC ENCLAVATION NEEDLE
ClassificationHook, Ophthalmic
Applicant OPHTEC USA 6421 CONGRESS AVE. STE 112 Boca Raton,  FL  33487
ContactRick Mccarley
CorrespondentRick Mccarley
OPHTEC USA 6421 CONGRESS AVE. STE 112 Boca Raton,  FL  33487
Product CodeHNQ  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-12
Decision Date2003-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08717819049176 K030471 000

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