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510(k) K772366

Device
BAG, DRAINAGEW/ADHESIVE; PROSTHESIS
Applicant
ATLANTIC SURGICAL
510(k) number
K772366
Product code
FON  
Decision
Substantially Equivalent (SESE)
Decision date
1978-01-26
Date received
1977-12-27
Regulation
876.5900
Classification name
Bag, Drainage, With Adhesive, Ostomy
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 FON  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K801504HOLLISTER DRAINAGE POUCHHollister, Inc.1980-08-12
K770826POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITEHowmedica Corp.1977-06-28

Legacy Summary#

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FDA Review#

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