FDA.reportPublic FDA data

510(k) K942526

Device
SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM
Applicant
LIFE MEDICAL SCIENCES, INC.
510(k) number
K942526
Product code
MKY  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-19
Date received
1994-05-27
Regulation
878.4320
Classification name
System, Skin Closure
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
GLENN A RAHMOELLER
Address
214 Carnegie Center Princeton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MKY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K002315WISEBANDS SKIN CLOSURE DEVICEWisebands , Ltd.2001-03-15
K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive Surgical Products, Inc.1998-09-08
K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)Progressive Surgical Products, Inc.1997-04-16
K962144PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.1997-01-14
K942425PROXIDERM (TENTATIVE)Progressive Surgical Products, Inc.1994-11-04

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases