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510(k) K760906

MONOMER VAPOR CONTAINMENT SYSTEM by Howmedica Corp. — Product Code JDY

K760906 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "MONOMER VAPOR CONTAINMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 11, 1976. The device falls under product code JDY (Evacuator, Vapor, Cement Monomer), a Class I device regulated under 21 CFR 888.4220. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 11, 1976
Date Received
October 26, 1976
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 Howmedica Corp.

  • K984251 — XIA SPINE SYSTEM (February 24, 1999)
  • K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEM (February 5, 1999)
  • K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEM (February 1, 1999)
  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)

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)
  • K780202 — MONOMER EVACUATION SYSTEM (February 21, 1978)
  • K770690 — MASK, VAPOR, MONOMER (July 21, 1977)

FDA data resources