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510(k) K833083

DERMA STRIP-TM SKIN CLOSURES by Howmedica Corp. — Product Code FPX

K833083 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "DERMA STRIP-TM SKIN CLOSURES". The FDA issued a decision of Substantially Equivalent on December 30, 1983. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1983
Date Received
September 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Adhesive, Closure, Skin
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
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)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)

Other clearances for product code FPX

  • K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
  • K952947 — DELPORE SKIN CLOSURE (July 24, 1995)
  • K952702 — DERMA SEAL (June 28, 1995)
  • K946321 — BIOSTRIP STERILE WOUND CLOSURE STRIP (January 12, 1995)
  • K931005 — DUKAL SKIN CLOSURE STRIP (July 14, 1993)
  • K921775 — SPYROFLEX WOUND CLOSURES (May 19, 1992)
  • K894802 — AWC BUTTERFLY WOUND CLOSURES (January 31, 1990)
  • K894205 — TECNOL SILK STRIP (July 25, 1989)
  • K874813 — OMED WOUND CLOSURE STRIPS (January 29, 1988)
  • K840945 — SKIN CLOSURE (October 31, 1984)

FDA data resources