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510(k) K790877

BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO by Stackhouse Assoc. — Product Code JDY

K790877 is an FDA 510(k) premarket notification submitted by Stackhouse Assoc. for the device "BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO". The FDA issued a decision of Substantially Equivalent on May 23, 1979. The device falls under product code JDY (Evacuator, Vapor, Cement Monomer), a Class I device regulated under 21 CFR 888.4220. Stackhouse Assoc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1979
Date Received
May 7, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Vapor, Cement Monomer
Device Class
Class I
Regulation Number
888.4220
Review Panel
OR
Submission Type

Other clearances by Stackhouse Assoc.

  • K912651 — AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM (July 8, 1991)
  • K910515 — FREEDOM MARK III SURGICAL HELMET SYSTEM (May 6, 1991)
  • K874512 — MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM (January 27, 1988)
  • K872935 — ANTI-INFECTION SHIELD (November 9, 1987)

Other clearances for product code JDY

  • K902167 — CONTAIN(TM) LASER PLUME FILTER (January 4, 1991)
  • K902056 — LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER (October 30, 1990)
  • K862509 — CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 (July 23, 1986)
  • K810542 — CEMENT FUME EVACUATOR TANK & FILTER (March 13, 1981)
  • K780202 — MONOMER EVACUATION SYSTEM (February 21, 1978)
  • K770690 — MASK, VAPOR, MONOMER (July 21, 1977)
  • K760906 — MONOMER VAPOR CONTAINMENT SYSTEM (November 11, 1976)

FDA data resources