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510(k) K920280

Device
SUTURE REMOVAL KIT, STERILE, DISPOSABLE
Applicant
TRINITY LABORATORIES, INC.
510(k) number
K920280
Product code
MCZ  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1992-05-11
Date received
1992-01-22
Regulation
878.4800
Classification name
Suture Removal Kit
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
PARTHA BASUMALLIK
Address
P.O. Box 4458 201 Kiley Dr. Salisbury MD US 21803 21803

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MCZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050656AMSINO SUTURE REMOVAL KITAmsino International, Inc.2005-05-02
K964827PROD. NO. 01-132 - SUTURE REMOVAL KITContinental Medical Laboratories, Inc.1997-02-14
K963714GRAND MEDICAL SUTURE REMOVAL KITGrand Medical Products1996-11-27
K943046SKIN STAPLE REMOVAL TRAYSSterile Concepts, Inc.1994-07-29
K941465SUTURE REMOVAL KITClinical Resources, Inc.1994-04-22
K931597CARAPACE INCISION AND DRAINAGE TRAYSCarapace, Inc.1993-11-05
K925015STERILE SUTURE REMOVAL KITCustomed, Inc.1993-06-07
K924834PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957)American Healthcare Supply Co., Inc.1993-03-23
K924835VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560American Healthcare Supply Co., Inc.1993-03-23
K922339SUTURE REMOVAL KITTransidyne General Corp.1992-12-11
K915827A.C.S. SUTURE REMOVAL KITAmerican Carolina Stamping1992-12-08
K920283DISPOSABLE SKIN STAPLE REMOVERTrinity Laboratories, Inc.1992-05-22
K910361SUTURE REMOVAL KITMegadyne Medical Products, Inc.1991-03-27
K812132STERILE SUTURE REMOVAL KITE.M. Adams1981-12-01

Legacy Summary#

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FDA Review#

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