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510(k) K862509

Device
CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000
Applicant
LIFESTREAM INT'L, INC.
510(k) number
K862509
Product code
JDY  
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-23
Date received
1986-07-01
Regulation
888.4220
Classification name
Evacuator, Vapor, Cement Monomer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MIKE BARBOUR
Address
525 Julie Rivers Dr. Suite 100 Sugar Land TX US 77478 77478

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JDY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K902167CONTAIN(TM) LASER PLUME FILTERArbor Technologies, Inc.1991-01-04
K902056LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTERHollister, Inc.1990-10-30
K810542CEMENT FUME EVACUATOR TANK & FILTERWalgen Medical Innoventions1981-03-13
K790877BIOVAC: LFA LASER FUME (SMOKE) EVACUATIOStackhouse Assoc.1979-05-23
K780202MONOMER EVACUATION SYSTEMMedishield, Inc.1978-02-21
K770690MASK, VAPOR, MONOMERHowmedica Corp.1977-07-21
K760906MONOMER VAPOR CONTAINMENT SYSTEMHowmedica Corp.1976-11-11

Legacy Summary#

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FDA Review#

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