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510(k) K834056

Device
SCHEIN COTTON ROLLS, NON-STERILE
Applicant
HENRY SCHEIN, INC.
510(k) number
K834056
Product code
EFN  
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-03
Date received
1983-11-23
Regulation
872.6050
Classification name
Cotton, Roll
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EFN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872810STRUNG DENTAL ROLLSAmerican Silk Sutures, Inc.1987-12-04
K871464MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STERMedgroup Enterprises, Inc.1987-04-30
K863764COTTON ROLLS, NON-STERILEThe Medical Group, Inc.1986-10-27
K861338DENTAL COTTON ROLLS, STERILE AND NON-STERILEIntl. Verbandstoff-Fabrik Schaffhau1986-08-06
K861727COTTON FILLED GAUZE SPONGES 2 X 2Cross Country Paper Products Corp.1986-07-10
K843539TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-Molnlycke A/S Hospital Products1985-05-23
K841327DENTAL COTTON ROLLSIntl. Verbandstoff-Fabrik Schaffhau1984-07-03
K830175STERILE COTTON ROLLS #3, 1 1/2Veratex Corp.1983-02-18
K812709STERILE DENTAL ROLLMedspec Corp.1981-10-23
K810830HOYT COTTON ROLLSHoyt Laboratories1981-04-14
K802429COTTON ROLLSWorldwide Surgical Gauze1980-10-23
K792391COTTON ROLL COMPRESSION CAPSParker Laboratories, Inc.1979-12-06
K770063DISP. ABSORBENT COMPRESSED FIBRE WAFERLorvic Corp.1977-01-14

Legacy Summary#

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FDA Review#

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