SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG

Plug, Punctum

SURGICAL SPECIALTIES CORP.

The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Sharpoint Ultraplug Extended Wear Plug.

Pre-market Notification Details

Device IDK020882
510k NumberK020882
Device Name:SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
ClassificationPlug, Punctum
Applicant SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
ContactElizabeth Lazaro
CorrespondentElizabeth Lazaro
SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
Product CodeLZU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-18
Decision Date2002-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841668114773 K020882 000
10848782023810 K020882 000
10848782023827 K020882 000
10848782024091 K020882 000
00851807007200 K020882 000
00851807007217 K020882 000
00851807007224 K020882 000
00851807007231 K020882 000
00841668114759 K020882 000
00841668114766 K020882 000
10848782023803 K020882 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.