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510(k) K854537

Device
HEADSTRAP
Applicant
LIFE DESIGN SYSTEMS, INC.
510(k) number
K854537
Product code
BTK  
Decision
Substantially Equivalent (SESE)
Decision date
1985-12-03
Date received
1985-11-13
Regulation
868.5560
Classification name
Strap, Head, Gas Mask
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GILBERT M KIRK
Address
11017 W. Layton Ave. Milwaukee WI US 53228 53228

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BTK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944949GENERAL ANESTHESIA SYSTEMVital Signs, Inc.1994-11-14
K914335STRAP, HEAD, GAS MASKVital Signs, Inc.1992-04-02
K853573MEDIPART FACE MASK HEADSTRAP MP-9100Medipart Jerry Alexander1985-10-29
K831008HEAD STRAPMedovations, Inc.1983-05-09
K810991HEADSTRAPRespironics, Inc.1981-04-29

Legacy Summary#

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FDA Review#

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