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510(k) K890376

Device
VAGINAL SPECULUM
Applicant
KINETIC MEDICAL PRODUCTS
510(k) number
K890376
Product code
HFD  
Decision
Substantially Equivalent (SESE)
Decision date
1989-02-27
Date received
1989-01-23
Regulation
884.1185
Classification name
Washer, Endometrial
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES I LAUGHNER
Address
4934 Peach St. Erie PA US 16509 16509

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K891037WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUEZinnanti Surgical Instruments, Inc.1989-03-17
K810558SKIN SCRUB TRAYAssociated Medical Products Co.1981-03-17

Legacy Summary#

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FDA Review#

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