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510(k) K943989

Device
LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT
Applicant
GABRIS SURGICAL CORP.
510(k) number
K943989
Product code
HFO  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-12
Date received
1994-08-16
Regulation
884.2700
Classification name
Recorder, Pressure, Intrauterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KENNETH A BELTRAN
Address
1432 N. Great Neck Rd., Suite 204 Virginia Beach VA US 23454 23454

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973850ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007Alexander Mfg. Co.1997-11-12
K791633UC-2000 UTERINE CATHERIZATION SYSTEMLife Support, Inc.1979-09-17
K780487FETAL MONITORING SYSTEMSonicaid, Inc.1978-05-09

Legacy Summary#

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FDA Review#

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