ALPHA MALLARD

Vehicle, Motorized 3-wheeled

ALPHA UNLIMITED, INC.

The following data is part of a premarket notification filed by Alpha Unlimited, Inc. with the FDA for Alpha Mallard.

Pre-market Notification Details

Device IDK893248
510k NumberK893248
Device Name:ALPHA MALLARD
ClassificationVehicle, Motorized 3-wheeled
Applicant ALPHA UNLIMITED, INC. 1610 NORTHGATE BLVD. Sarasota,  FL  34234
ContactGordon Peterson
CorrespondentGordon Peterson
ALPHA UNLIMITED, INC. 1610 NORTHGATE BLVD. Sarasota,  FL  34234
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-28
Decision Date1989-05-26

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