CAUTERIZATION SMOKE EVACUATOR

Electrosurgical, Cutting & Coagulation & Accessories

APPLIED MEDICAL TECHNOLOGIES

The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Cauterization Smoke Evacuator.

Pre-market Notification Details

Device IDK971758
510k NumberK971758
Device Name:CAUTERIZATION SMOKE EVACUATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant APPLIED MEDICAL TECHNOLOGIES 15653 NEO PKWY. Cleveland,  OH  44128 -3150
ContactThomas W Parkinson
CorrespondentThomas W Parkinson
APPLIED MEDICAL TECHNOLOGIES 15653 NEO PKWY. Cleveland,  OH  44128 -3150
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-13
Decision Date1997-07-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842071109943 K971758 000
00842071109929 K971758 000
00842071109912 K971758 000
00842071109899 K971758 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.