16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)

Electrocautery, Gynecologic (and Accessories)

AARON MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for 16 Electrodes (blade, Ball, Needle & Loop).

Pre-market Notification Details

Device IDK931338
510k NumberK931338
Device Name:16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
ClassificationElectrocautery, Gynecologic (and Accessories)
Applicant AARON MEDICAL INDUSTRIES 1640 CENTRAL AVE. St. Petersburg,  FL  33712
ContactRobert Saron
CorrespondentRobert Saron
AARON MEDICAL INDUSTRIES 1640 CENTRAL AVE. St. Petersburg,  FL  33712
Product CodeHGI  
CFR Regulation Number884.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-16
Decision Date1994-02-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00192896011175 K931338 000
20884524000173 K931338 000
20884524000180 K931338 000
20884524000197 K931338 000
20884524000203 K931338 000
20884524000210 K931338 000
20884524000227 K931338 000
20884524000234 K931338 000
40080196167464 K931338 000
40080196916277 K931338 000
40080196916284 K931338 000
40080196916307 K931338 000
40080196916345 K931338 000
40080196916352 K931338 000
20193489198536 K931338 000
20193489198703 K931338 000
20193489199601 K931338 000
20884524000166 K931338 000

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