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510(k) K921852

Device
4 SURE TM RECTAL TUBE
Applicant
BOSTON PACIFIC MEDICAL, INC.
510(k) number
K921852
Product code
KMO  
Decision
Substantially Equivalent (SESE)
Decision date
1993-10-08
Date received
1992-04-17
Regulation
880.5160
Classification name
Binder, Elastic
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RANDAL GREEN
Address
636 Beacon St. Unit 204 Boston MA US 02215 02215

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KMO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893809COUGH PILLOWCustom Hospitals Products1989-08-28
K883214THORACIC SUPPORT SYSTEMStorer Medical Products1989-01-17
K882592HEART HUGGER STERNUM SUPPORT HARNESSGeneral Cardiac Technology, Inc.1988-09-20
K792629STERILIZATION PROCESS/T-BINDERProcter & Gamble Mfg. Co.1980-01-11

Legacy Summary#

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FDA Review#

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