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510(k) K931607

Device
MEDDRAINS
Applicant
ARMM, INC.
510(k) number
K931607
Product code
GBN  
Decision
Substantially Equivalent (SESE)
Decision date
1993-08-06
Date received
1993-04-01
Regulation
878.4200
Classification name
Catheter, Pediatric, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL E HAMLIN
Address
17744 Sampson Ln. Huntington Beach CA US 92647 92647

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K802783SURGEONS CHOICE STAPLE, REMOVE/IMPLANTHospital Products Intl.1980-12-16

Legacy Summary#

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FDA Review#

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