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510(k) K944067

Device
PEANUT WAND, MODIFICATION
Applicant
IDEAL MEDICAL, INC.
510(k) number
K944067
Product code
GCS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-08
Date received
1994-07-26
Regulation
876.1500
Classification name
Endoscope, Battery-powered And Accessories
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ELIZABETH M PAUL
Address
12167 49th St. N. P.O. Box 17327 Clearwater FL US 34622 34622

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GCS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944062LAPRASCOPIC GRASPERInstrument Makar, Inc.1995-02-23
K933201AESCULAP TROCAR INSTRUMENT SETAesculap, Inc.1993-09-13
K93276210.0MM SUCTION/IRRIGATION PROBE & TUBING KITInman Medical Corp.1993-08-31
K933371IMC ENDOSCOPIC INSTRUMENT HOLDERInman Medical Corp.1993-08-06
K924134LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESSLeisegang Medical, Inc.1993-07-02
K931340GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTORBaxter Healthcare Corp1993-07-01
K925276M.I.S. TROCAR-CANNULAM.I.S. Technology, Inc.1993-05-24
K921006LAPAROSCOPIC RETRACTOR SYSTEMLaparomed Corp.1992-07-28

Legacy Summary#

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FDA Review#

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