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510(k) K850750

Device
DISPOSABLE UROSTOMY POUCH
Applicant
BIOLOG, INC.
510(k) number
K850750
Product code
EXB  
Decision
Substantially Equivalent (SESE)
Decision date
1985-05-23
Date received
1985-02-25
Regulation
876.5900
Classification name
Collector, Ostomy
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DON BARNBY
Address
3447 Investment Blvd. Suite 3 Hayward CA US 94545 94545

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EXB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252140Heylo™ SystemColoplast Corp.2025-10-06
K181643SmartBag (SmartPouch)11 Health Technologies Limited2018-11-16
K140938OSTOM-I ALERT11 Health and Technologies, LLC2014-10-10
K922730LAKE OSTOMY CARE SETLake Medical Products, Inc.1993-12-30
K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.1988-12-08
K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/S1988-07-13
K880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.1988-05-20
K872294COMBINATION NITE DRAINAGE UNITArnold Technologies1987-12-29
K873929'CATCH-IT' OR FECAL CONTAINMENT DEVICEMidwest Medical Co.1987-12-03
K871526ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDERCox Family Laboratories, Inc.1987-10-13
K871738OSTO-PUREClearchem Corp.1987-08-12
K871628PALEX (R) OSTOMYIndustrias Palex C/O Dma Med-Chem Corp.1987-07-08
K870577E-Z LOOPJohn F. Greer Co., Inc.1987-04-17
K870531EZ TAC FILTERJohn F. Greer Co., Inc.1987-04-10
K870136PERSONAL PUNCHArnold Technologies1987-04-01

Legacy Summary#

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FDA Review#

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