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510(k) K901425

Device
PYLORIC BALLOON DILATOR
Applicant
TELEMED SYSTEMS, INC.
510(k) number
K901425
Product code
FAT  
Decision
Substantially Equivalent (SESE)
Decision date
1990-06-21
Date received
1990-03-26
Regulation
876.5365
Classification name
Bougie, Esophageal, And Gastrointestinal, Gastro-urology
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN A CHAVES
Address
8 Kane Industrial Dr. Hudson MA US 01749 01749

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FAT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K133439PILLING ESOPHAGEAL BOUGIESTeleflexmedical, Inc.2014-06-16
K983220STRYKER INFRAVISION ESOPHAGEAL KITStryker Endoscopy1999-06-04
K972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)Medovations, Inc.1998-02-02
K960173INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KITGabriel Medical, Inc.1996-06-27
K843186ESKA MULTISTAGE ESOPHAGEAL BOUGIEDacomed Corp.1985-01-18
K842679ESOPHAGEAL DILATOR SETMill-Rose Laboratory1984-10-02
K780471GASTRIC LAVAGE KITGaymar Industries, Inc.1978-06-02

Legacy Summary#

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FDA Review#

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