OMED WOUND CLOSURE STRIPS— 510(k) K874813

Clearance details

Applicant

Oxboro Medical Intl., Inc.

Product code

Code FPX

Device class

Class 1

Regulation

21 CFR 880.5240

Advisory panel

General Hospital

Date received

1987-11-24

Decision date

1988-01-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bloomington, MN, US

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• K946321 — BIOSTRIP STERILE WOUND CLOSURE STRIP1995-01-12
• K931005 — DUKAL SKIN CLOSURE STRIP1993-07-14

• K953068 — OXBORO-MEDICAL FOAM INSTRUMENT HOLDER1996-01-23
• K952787 — FOAM INSTRUMENT GUARD1995-12-28
• K952783 — OXBORO-MEDICAL PIN COVERS1995-09-15
• K952784 — OXBORO-MEDICAL CAUTERY TIP CLEANER1995-07-13
• K880028 — OMED DISPOSABLE SCALPEL1988-01-29

• Z-1988-2013 — Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staplesClass II·Terminated·Aspen Surgical Products, Inc.·20130718

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K874813.