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510(k) K903532

Device
UNNA-SLEEVE(TM)
Applicant
ACI MEDICAL, INC.
510(k) number
K903532
Product code
LLK  
Decision
Substantially Equivalent (SESE)
Decision date
1990-11-02
Date received
1990-08-06
Regulation
880.5780
Classification name
Legging, Compression, Non-inflatable
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ED ARKANS
Address
9249 Glenoaks Bl. Sun Valley CA US 91352 91352

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873368TECNOL COMPRESSION KNEE DRESSINGTecnol New Jersey Wound Care, Inc.1987-12-11
K871889COMPRESSION LEGGING DEVICEA-T Surgical Mfg. Co., Inc.1987-08-04
K834460MODEL 1888 ALPHA COS/RESPIRATION CARSpacelabs, Inc.1984-02-13

Legacy Summary#

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FDA Review#

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