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510(k) K834460

Device
MODEL 1888 ALPHA COS/RESPIRATION CAR
Applicant
SPACELABS, INC.
510(k) number
K834460
Product code
LLK  
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-13
Date received
1983-12-19
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K903532UNNA-SLEEVE(TM)Aci Medical, Inc.1990-11-02
K873368TECNOL COMPRESSION KNEE DRESSINGTecnol New Jersey Wound Care, Inc.1987-12-11
K871889COMPRESSION LEGGING DEVICEA-T Surgical Mfg. Co., Inc.1987-08-04

Legacy Summary#

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FDA Review#

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