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510(k) K951231

Device
ORTHOPEDIC PACKS
Applicant
STERILE CONCEPTS, INC.
510(k) number
K951231
Product code
GAN  
Decision
Substantially Equivalent (SESE)
Decision date
1995-12-01
Date received
1995-03-20
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
DARREN REEVES
Address
5100 Commerce Rd.. Richmond VA US 23234 23234

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
K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)ETHICON, Inc.1996-03-28
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#

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FDA Review#

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