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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Vapor, Cement Monomer
510(k) Number K790877
Device Name BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO
Applicant
Stackhouse Assoc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Stackhouse Assoc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.4220
Classification Product Code
JDY  
Date Received05/07/1979
Decision Date 05/23/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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