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510(k) K904248

Device
MODEL GLASE 210 HOLMIUM LASER SYSTEM
Applicant
CHARLES L. ROSE AND CO., INC.
510(k) number
K904248
Product code
HGF  
Decision
Substantially Equivalent (SESE)
Decision date
1990-12-14
Date received
1990-09-17
Regulation
884.5070
Classification name
Source, Abortion Unit, Vacuum
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHARLES L ROSE
Address
1963 Rock St. Suite #17 Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HGF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945179BOTTLE COLLECTION SETMedgyn Products, Inc.1995-01-26
K905115BIOVISION ENDOCULAR PROBEDouglas James Donaldson Compliance Services1991-02-11
K890787O-020 LASER INDIRECT OPHTHALMOSCOPEHgm Medical Laser Systems, Inc.1989-03-24

Legacy Summary#

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FDA Review#

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