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510(k) K861142

Device
MASTER KIT B
Applicant
PRO-LAB, INC.
510(k) number
K861142
Product code
LRP  
Decision
Substantially Equivalent - With Drug (SESD)
Decision date
1986-07-10
Date received
1986-03-26
Regulation
878.4800
Classification name
Tray, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAN MCDONALD
Address
Post Office Box 11276 Birmingham AL US 35201 35201

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LRP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963723LACERATION TRAYGrand Medical Products1996-11-27
K951811OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACKOsteotech, Inc.1995-05-31
K940239EYE TRAYCush Medical Products1994-06-28
K935621CUSTOM ENT PACKSAssociated Medical1994-03-30
K940646ORTHOPEDIC TRAY PRODUCT LINECushindu1994-03-11
K940444GENERAL SURGERY TRAYCush Medical Products1994-03-07
K922126HOSPITAL KIT ENT 1125Savoy Medical Supply Co., Inc.1993-01-21
K912105EYE TRAYMedical Device Inspection Co., Inc.1991-08-29
K903962INSTRUMENTS FOR ONE TIME USE/ DISPOSABLEApk Technology1991-07-29
K903963KITS AND TRAYS FOR ONE TIME USE ONLYApk Technology1991-07-29
K905462PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURESAngiosystems, Inc.1991-02-06
K903544CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITSJ.J. Skinner, Inc.1990-08-31
K890071STERILE LACERATION TRAYMumtaz I. Malik1989-01-24
K883098SITE STERILIZATION TRAYS FOR OPHTHALMIC USESite Microsurgical Systems, Inc.1988-08-18
K882275STERILE PACK (PROCEDURAL TRAY/KITS)East Texas Lighthouse For the Blind1988-07-18

Legacy Summary#

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FDA Review#

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