STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT

Nebulizer (direct Patient Interface)

DHD HEALTHCARE CORP.

The following data is part of a premarket notification filed by Dhd Healthcare Corp. with the FDA for Stealth Pilot Kit/ Stealth Spacer/face Mask Kit.

Pre-market Notification Details

Device IDK981167
510k NumberK981167
Device Name:STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
ClassificationNebulizer (direct Patient Interface)
Applicant DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville,  NY  13163
ContactJean Wallace
CorrespondentJean Wallace
DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville,  NY  13163
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-01
Decision Date1998-06-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00349502208034 K981167 000
00349502208027 K981167 000
30349502208011 K981167 000

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