FDA.reportPublic FDA data

510(k) K790877

Device
BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO
Applicant
STACKHOUSE ASSOC.
510(k) number
K790877
Product code
JDY  
Decision
Substantially Equivalent (SESE)
Decision date
1979-05-23
Date received
1979-05-07
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#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K862509CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000Lifestream Int'L, Inc.1986-07-23
K810542CEMENT FUME EVACUATOR TANK & FILTERWalgen Medical Innoventions1981-03-13
K780202MONOMER EVACUATION SYSTEMMedishield, Inc.1978-02-21
K770690MASK, VAPOR, MONOMERHowmedica Corp.1977-07-21
K760906MONOMER VAPOR CONTAINMENT SYSTEMHowmedica Corp.1976-11-11

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases