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510(k) K952470

Device
ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.
Applicant
R-GROUP INTL.
510(k) number
K952470
Product code
GCD  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-28
Date received
1995-05-26
Regulation
878.4200
Classification name
Connector, Catheter
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KERRY ANNE KAHN
Address
P.O. Box 7235 2321 NW 66th Ct., Suite W4 Gainesville FL US 32653 32653

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GCD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940198L-CATH CONNECTOR ASSEMBLYLuther Medical Products, Inc.1994-12-15
K863446ANGIOMED HIGH PRESSURE CONNECTORSAngiomed U.S., Inc.1986-09-23
K851196INCISION DRAINSil-Med Corp.1985-06-04
K851921Y CONNECTORSil-Med Corp.1985-05-17
K760382CONNECTORSB. Braun Instruments1976-11-02
K760524CATHETER CONNECTOR, ARGYLE TUBINGSherwood Medical Industries1976-11-02
K760203TUBE, STERILE NON-CONDUCTIVE CONNECTINGIpco Corp.1976-07-19

Legacy Summary#

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FDA Review#

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