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510(k) K840492

Device
SUN-LITE BLUE SLIT
Applicant
SUNCOAST MEDICAL MANUFACTURERS, INC.
510(k) number
K840492
Product code
HTP  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-09
Date received
1984-02-06
Regulation
888.4540
Classification name
File
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
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 HTP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931733INTERMEDICS ORTHOPEDICS REAMERSIntermedics Orthopedics1994-01-26
K870842SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASPWarsaw Orthopedic, Inc.1987-05-27
K862659CONCEPT ARTHROSCOPY RASPConcept, Inc.1986-09-02
K8419814MM & 5MM FILEStainless Mfg., Inc.1984-06-19

Legacy Summary#

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FDA Review#

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