SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR

Insufflator, Laparoscopic

DEKNATEL, INC.

The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Snowden-pencer Computerized High Flow Insufflator.

Pre-market Notification Details

Device IDK962683
510k NumberK962683
Device Name:SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
ClassificationInsufflator, Laparoscopic
Applicant DEKNATEL, INC. 49 PLAIN ST. North Attleboro,  MA  02760
ContactDiane E Minear, Rac
CorrespondentDiane E Minear, Rac
DEKNATEL, INC. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-10
Decision Date1997-01-10
Summary:summary

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