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510(k) K952947

DELPORE SKIN CLOSURE by Bitco Intl. — Product Code FPX

K952947 is an FDA 510(k) premarket notification submitted by Bitco Intl. for the device "DELPORE SKIN CLOSURE". The FDA issued a decision of Substantially Equivalent on July 24, 1995. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1995
Date Received
June 26, 1995
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 for product code FPX

  • K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
  • 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)
  • K842621 — SUTURE STRIP (October 25, 1984)

FDA data resources