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510(k) K946321

BIOSTRIP STERILE WOUND CLOSURE STRIP by Cornelia Damsky, Inc. — Product Code FPX

K946321 is an FDA 510(k) premarket notification submitted by Cornelia Damsky, Inc. for the device "BIOSTRIP STERILE WOUND CLOSURE STRIP". The FDA issued a decision of Substantially Equivalent on January 12, 1995. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240. Cornelia Damsky, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1995
Date Received
December 28, 1994
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 Cornelia Damsky, Inc.

  • K001322 — PERFORMER 30 HPS (June 30, 2000)
  • K852857 — 4 X 4' GAUZE PAD (July 26, 1985)
  • K852858 — STRETCH BANDAGE (July 26, 1985)

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)
  • 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)
  • K842621 — SUTURE STRIP (October 25, 1984)

FDA data resources