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510(k) K924440

Device
U.S. MEDICAL PS-7000 DIALYSIS SCALE
Applicant
U.S. MEDICAL CORP.
510(k) number
K924440
Product code
KOE  
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-26
Date received
1992-09-01
Regulation
876.5520
Classification name
Dilator, Urethral
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRUCE E DODSON
Address
12 Scovil Rd. Higgaum CT US 06441 06441

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KOE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.2020-01-02
K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.2004-03-03
K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.1997-10-10
K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.1996-10-21
K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.1996-10-18
K920551120 FR OPTILUME PROSTATE BALLOON DILATORAmerican Medical Systems, Inc.1992-10-28
K922349DOWD(TM) IIBoston Scientific Corp1992-08-14
K920711ENTRAC URETHRAL BALLOON DILATATION CATHETERAmerican Medical Systems, Inc.1992-05-06
K913477APEX(TM) PROSTATIC BALLOON DILATION CATHETERPeripheral Systems Group1991-12-27
K902585UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETERAdvanced Surgical Intervention, Inc.1990-08-27
K896713ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.Advanced Surgical Intervention, Inc.1990-05-24
K900760AMS OPTILUME INFLATION SYRINGEAmerican Medical Systems, Inc.1990-05-17
K900761AMS OPTILUME(TM) PROSTATE BALLOON DILATORAmerican Medical Systems, Inc.1990-05-17
K892855URETHRAL BALLOON DILATION CATHETER SETCook Urological, Inc.1989-11-17
K873295PROSTATIC URETHRO. BALLOON DILATATION CATHETERMedi-Tech, Inc.1989-07-31

Legacy Summary#

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FDA Review#

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