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510(k) K810542

CEMENT FUME EVACUATOR TANK & FILTER by Walgen Medical Innoventions — Product Code JDY

K810542 is an FDA 510(k) premarket notification submitted by Walgen Medical Innoventions for the device "CEMENT FUME EVACUATOR TANK & FILTER". The FDA issued a decision of Substantially Equivalent on March 13, 1981. The device falls under product code JDY (Evacuator, Vapor, Cement Monomer), a Class I device regulated under 21 CFR 888.4220. Walgen Medical Innoventions has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1981
Date Received
February 27, 1981
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 Walgen Medical Innoventions

  • K861292 — CASTALERT (May 12, 1986)
  • K810433 — LOWER EXTREMITY SUPPORT SYSTEM-LESS (March 13, 1981)

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)
  • K790877 — BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO (May 23, 1979)
  • 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