HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER

Nebulizer, Medicinal, Non-ventilatory (atomizer)

SALTER LABS

The following data is part of a premarket notification filed by Salter Labs with the FDA for Hand Held Pheumatic Powered (disposable) Nebulizer.

Pre-market Notification Details

Device IDK870027
510k NumberK870027
Device Name:HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER
ClassificationNebulizer, Medicinal, Non-ventilatory (atomizer)
Applicant SALTER LABS P.O. BOX 608 Arvin,  CA  93203
ContactJames N Curti
CorrespondentJames N Curti
SALTER LABS P.O. BOX 608 Arvin,  CA  93203
Product CodeCCQ  
CFR Regulation Number868.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-05
Decision Date1987-03-16

NIH GUDID Devices

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