HAND-TROL S

Electrosurgical Device

ASPEN LABS

The following data is part of a premarket notification filed by Aspen Labs with the FDA for Hand-trol S.

Pre-market Notification Details

Device IDK931215
510k NumberK931215
Device Name:HAND-TROL S
ClassificationElectrosurgical Device
Applicant ASPEN LABS 14603 E. FREMONT AVE. Englewood,  CO  80112
ContactJane Johnson
CorrespondentJane Johnson
ASPEN LABS 14603 E. FREMONT AVE. Englewood,  CO  80112
Product CodeDWG  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-10
Decision Date1994-03-28

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