EXHALATION VALVE

Valve, Non-rebreathing

INTERSURGICAL, INC.

The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Exhalation Valve.

Pre-market Notification Details

Device IDK984481
510k NumberK984481
Device Name:EXHALATION VALVE
ClassificationValve, Non-rebreathing
Applicant INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool,  NY  13088
ContactThomas R Gunerman
CorrespondentThomas R Gunerman
INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool,  NY  13088
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-16
Decision Date1999-01-29

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