REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES

Laparoscope, General & Plastic Surgery

SAC, LLC DBA PINNACLE MEDICAL SURGICAL

The following data is part of a premarket notification filed by Sac, Llc Dba Pinnacle Medical Surgical with the FDA for Reusable, Disposable Laparoscopic Instrument And Surgical Device And Accessories.

Pre-market Notification Details

Device IDK101733
510k NumberK101733
Device Name:REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
ClassificationLaparoscope, General & Plastic Surgery
Applicant SAC, LLC DBA PINNACLE MEDICAL SURGICAL P.O. BOX 782108 Orlando,  FL  32878 -2108
ContactDave Strain
CorrespondentDave Strain
SAC, LLC DBA PINNACLE MEDICAL SURGICAL P.O. BOX 782108 Orlando,  FL  32878 -2108
Product CodeGCJ  
Subsequent Product CodeEYN
Subsequent Product CodeFMT
Subsequent Product CodeFPB
Subsequent Product CodeHIF
Subsequent Product CodeJOK
Subsequent Product CodeNGY
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-21
Decision Date2011-06-06

NIH GUDID Devices

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