FDA.reportPublic FDA data

510(k) K960653

Device
MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
Applicant
ETHICON, INC.
510(k) number
K960653
Product code
GAN  
Decision
Substantially Equivalent (SESE)
Decision date
1996-03-28
Date received
1996-02-15
Regulation
878.4830
Classification name
Suture, Absorbable, Synthetic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN D PAULSON, PH.D.
Address
Rte. 22 W. P.O. Box 151 Somerville NJ US 08876 08876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GAN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003015SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBDSurgical Specialties Corp2000-12-15
K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDETHICON, Inc.1996-12-18
K951231ORTHOPEDIC PACKSSterile Concepts, Inc.1995-12-01
K920978ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYEDETHICON, Inc.1994-02-15
K895579POLYSORB SYNTHETIC ABSORBABLE SUTUREUnited States Surgical, A Division of Tyco Healthc1990-07-05
K900198DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.American Cyanamid Co.1990-07-05

Legacy Summary#

summary

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