LAPAROSCOPIC DISSECTOR

Electrosurgical, Cutting & Coagulation & Accessories

APPLIED MEDICAL RESOURCES CORP.

The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Laparoscopic Dissector.

Pre-market Notification Details

Device IDK103282
510k NumberK103282
Device Name:LAPAROSCOPIC DISSECTOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactFrans Vandenbroek
CorrespondentCasey Conry
UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville,  NY  11747
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-11-05
Decision Date2010-11-16
Summary:summary

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