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510(k) K882694

Device
FIXATION DEVICE, TRACH TUBE
Applicant
BIOSEAL
510(k) number
K882694
Product code
CBH  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-15
Date received
1988-06-27
Regulation
868.5770
Classification name
Device, Fixation, Tracheal Tube
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM L RUNION
Address
350 N. Palm Brea CA US 92621 92621

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CBH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140097AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEMApplied Medical Technology, Inc.2014-09-24
K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280Dale Medical Products, Inc.1997-01-28
K942529HCI TUBE STABILIZERHealth Care Contracts, Inc.1995-06-14
K951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSDale Medical Products, Inc.1995-04-24
K950930TRACHE-TITEThe Varner Group, Inc.1995-03-22
K950318FLEX BLUEKing Systems Corp.1995-02-13
K942395ENDOTRACHEAL TUBE HOLDERS.T.I. Medical Products Corp.1994-06-30
K934288HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BARNeo-Tech, Inc.1994-06-09
K942016TRACH TIE, VENTILATOR TUBING HOLDERGarrett Medical Products1994-05-24
K941384TRAKEEZErgomed, Inc.1994-04-19
K940448NETOH ENDOTRACHEAL TUBE HOLDERMedical Accessory Services, Inc.1994-02-22
K936094PREPARE LOCKPrepare, Inc.1994-02-03
K935171STABILTRACHB&B Medical Technologies, Inc.1993-12-02
K933420BREATHING TUBE SUPPORTBlake Medical, Inc.1993-10-13
K933781ANTI-DISCONNECTION MECHANISMHammer-Plane, Inc.1993-09-22

Legacy Summary#

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FDA Review#

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