FRASER HARLAKE NITRONOX SCAVENGER

Apparatus, Gas-scavenging

FRASER HARLAKE, INC.

The following data is part of a premarket notification filed by Fraser Harlake, Inc. with the FDA for Fraser Harlake Nitronox Scavenger.

Pre-market Notification Details

Device IDK821744
510k NumberK821744
Device Name:FRASER HARLAKE NITRONOX SCAVENGER
ClassificationApparatus, Gas-scavenging
Applicant FRASER HARLAKE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCBN  
CFR Regulation Number868.5430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-14
Decision Date1982-06-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816711020547 K821744 000
00816711020530 K821744 000
00816711020479 K821744 000
00816711020462 K821744 000
00816711020455 K821744 000
00816711020448 K821744 000
00816711020431 K821744 000
00816711023951 K821744 000
00816711020424 K821744 000

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