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510(k) K874813

OMED WOUND CLOSURE STRIPS by Oxboro Medical Intl., Inc. — Product Code FPX

K874813 is an FDA 510(k) premarket notification submitted by Oxboro Medical Intl., Inc. for the device "OMED WOUND CLOSURE STRIPS". The FDA issued a decision of Substantially Equivalent on January 29, 1988. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240. Oxboro Medical Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1988
Date Received
November 24, 1987
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 Oxboro Medical Intl., Inc.

  • K953068 — OXBORO-MEDICAL FOAM INSTRUMENT HOLDER (January 23, 1996)
  • K952787 — FOAM INSTRUMENT GUARD (December 28, 1995)
  • K952783 — OXBORO-MEDICAL PIN COVERS (September 15, 1995)
  • K952784 — OXBORO-MEDICAL CAUTERY TIP CLEANER (July 13, 1995)
  • K880028 — OMED DISPOSABLE SCALPEL (January 29, 1988)

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)
  • K840945 — SKIN CLOSURE (October 31, 1984)
  • K842621 — SUTURE STRIP (October 25, 1984)

FDA data resources