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510(k) K933798

Device
NU-PREP GEL
Applicant
CADWELL LABORATORIES, INC.
510(k) number
K933798
Product code
GXB  
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-22
Date received
1993-08-04
Regulation
882.1500
Classification name
Esthesiometer
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CARLTON M CADWELL
Address
909 N Kellogg St. Kennewick WA US 99336 99336

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143068Medical Monofilament Sensory Screening TooolMedical Monofilament Manufacturing2015-01-14
K871571NEUROTIPS(TM)Ulster Scientific, Inc.1987-06-18
K801907ALGESIOMETERRowan Products, Inc.1980-09-16
K772406AESTHESIOMETERFred Sammons, Inc.1978-01-06
K771847TEMP-TESTERJablecki, Charles, Dr.1977-11-02
K761133AESTHESIOMETERFred Sammons, Inc.1976-12-02

Legacy Summary#

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FDA Review#

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