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510(k) K780202

MONOMER EVACUATION SYSTEM by Medishield, Inc. — Product Code JDY

K780202 is an FDA 510(k) premarket notification submitted by Medishield, Inc. for the device "MONOMER EVACUATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 21, 1978. The device falls under product code JDY (Evacuator, Vapor, Cement Monomer), a Class I device regulated under 21 CFR 888.4220. Medishield, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1978
Date Received
February 7, 1978
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 Medishield, Inc.

  • K781103 — SPECTRASCAN (September 27, 1978)
  • K780645 — HMD-2000 BATTERY-POWERED MINI-DRILL, THE (May 3, 1978)
  • K780646 — AIR-PWOERED COLDRILL (April 28, 1978)
  • K770161 — MICROFENESTRATED HIP REPLACEMENT COMPON. (January 26, 1977)
  • K761020 — ANKLE (FREEMAN-SWANSON) (November 23, 1976)
  • K761021 — ANKLE INSTRUMENTS (FREEMAN-SWANSON) (November 23, 1976)
  • K760668 — SELECTATEC SYSTEM (September 27, 1976)

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)
  • K790877 — BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO (May 23, 1979)
  • K770690 — MASK, VAPOR, MONOMER (July 21, 1977)
  • K760906 — MONOMER VAPOR CONTAINMENT SYSTEM (November 11, 1976)

FDA data resources