DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900

Insufflator, Laparoscopic

SUN MEDICAL, INC.

The following data is part of a premarket notification filed by Sun Medical, Inc. with the FDA for Disposable, Filtered Insufflation Tubing, 92-900.

Pre-market Notification Details

Device IDK921963
510k NumberK921963
Device Name:DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900
ClassificationInsufflator, Laparoscopic
Applicant SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington,  TX  76006
ContactDavid Lee
CorrespondentDavid Lee
SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington,  TX  76006
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-27
Decision Date1992-09-11

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