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510(k) Data Aggregation
K Number
K062779Device Name
DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)
Manufacturer
NEW WAVE SURGICAL CORPORATION
Date Cleared
2006-10-05
(17 days)
Product Code
GCJ, KOG
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NEW WAVE SURGICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
DELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
Device Description
The Defogging Endoscopic Lens Protector (D.E.L.P.) is a small, sterile, disposable, multi-function device. It is designed to store and apply anti-fog surfactant solutions to the distal lens of endoscopes. This is intended to reduce fogging on endoscopes by applying anti-fog solution to the distal lens.
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