510(k) K022387

Device
CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC
Applicant
CRAFTMATIC ORGANIZATION, INC.
510(k) number
K022387
Product code
LLI  
Decision
Substantially Equivalent (SESE)
Decision date
2002-09-19
Date received
2002-07-23
Regulation
880.5100
Classification name
Bed, Therapeutic, Ac-powered, Adjustable Home-use
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAUL D RUBIN
Address
2550 M St. NW Washington DC US 20037 20037

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LLI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K840787CRAFTMATIC ELECTRIC ADJUSTABLE BEDContour, Inc.1984-06-13

Legacy Summary#

summary

FDA Review#

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