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510(k) K780137

Device
CLAMP, INCONTINENCE, BAUMRUCKER
Applicant
GREENWALD SURGICAL CO., INC.
510(k) number
K780137
Product code
FHA  
Decision
Substantially Equivalent (SESE)
Decision date
1978-04-28
Date received
1978-01-25
Regulation
876.5160
Classification name
Clamp, Penile
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FHA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974040C3 EXTERNAL MALE BLADDER CONTROL DEVICETimm Research Co.1998-07-14
K971992UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)Uromed Corp.1997-08-01
K970308MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCEMentor Urology, Inc.1997-04-02
K964580CAP-AID (IMPROVED)Nebel, Inc.1997-01-10
K955810U-TEXLaborie Medical Technologies, Ltd.1996-01-24
K954959CAP-AIDNebl, Inc.1995-12-06
K952841THE ASSISTANTApple Medical Corp.1995-08-18
K896160WILLIAMS PENILE ANESTHETIC RETAINERCook Urological, Inc.1990-02-16
K885323DACOMED EXTERNAL MALE CONTINENCE DEVICEDacomed Corp.1989-02-08
K863227COOK-VPI CONTINENCE CUFFCook Urological, Inc.1987-02-03

Legacy Summary#

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FDA Review#

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