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510(k) K973850

Device
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
Applicant
ALEXANDER MFG. CO.
510(k) number
K973850
Product code
HFO  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-12
Date received
1997-10-08
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
KEN HEIMENDINGER
Address
1511 S Garfield Pl. Mason City IA US 50401 50401

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
K943989LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENTGabris Surgical Corp.1994-09-12
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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