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510(k) K936026

Device
COOK LAPAROSCOPIC MINI RETRACTOR SET
Applicant
COOK UROLOGICAL, INC.
510(k) number
K936026
Product code
HFI  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-11
Date received
1993-12-17
Regulation
884.4160
Classification name
Coagulator, Culdoscopic (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICK LYKINS
Address
1100 W. Morgan St. P.O. Box 271 Spencer IN US 47460 47460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HFI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151567ENDOPLUS hand-held laparoscopic instrumentsEndoplus2015-12-23
K925957SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USEZinnanti Surgical Instruments, Inc.1994-06-07
K925960FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USEZinnanti Surgical Instruments, Inc.1994-06-07
K924148DIAMOND-SHARP(R) TROCARSSnowden-Pencer1994-02-28
K925114LAPAROSCOPIC INSTRUMENTSEndo Technic Corp.1994-02-28
K930571REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATINGNumed Technologies, Inc.1994-02-01
K844053CANON 60 DEGREE FUNDUS CAMERA CF-60SCanon USA, Inc.1984-12-19

Legacy Summary#

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FDA Review#

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