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510(k) K770690

MASK, VAPOR, MONOMER by Howmedica Corp. — Product Code JDY

K770690 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "MASK, VAPOR, MONOMER". The FDA issued a decision of Substantially Equivalent on July 21, 1977. 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
July 21, 1977
Date Received
April 13, 1977
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)
  • K760906 — MONOMER VAPOR CONTAINMENT SYSTEM (November 11, 1976)

FDA data resources