MICRO ENDOSCOPIC ELECTRODE (ME2)

Laparoscope, General & Plastic Surgery

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Micro Endoscopic Electrode (me2).

Pre-market Notification Details

Device IDK931281
510k NumberK931281
Device Name:MICRO ENDOSCOPIC ELECTRODE (ME2)
ClassificationLaparoscope, General & Plastic Surgery
Applicant Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
ContactAzin Parhizgar
CorrespondentAzin Parhizgar
Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-09
Decision Date1993-07-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704042761 K931281 000

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