SKIN CLOSURE— 510(k) K840945

Substantially Equivalent

Gainor Medical

FDA 510(k) clearance K840945 for SKIN CLOSURE, Substantially Equivalent on 1984-10-31. Applicant: Gainor Medical. Device class: 1.

Clearance details

Applicant: Gainor Medical
Product code: Code FPX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1984-03-05
Decision date: 1984-10-31
Decision: Substantially Equivalent
Clearance type: Traditional

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPX

K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH1997-05-09
K952947 — DELPORE SKIN CLOSURE1995-07-24
K952702 — DERMA SEAL1995-06-28
K946321 — BIOSTRIP STERILE WOUND CLOSURE STRIP1995-01-12
K931005 — DUKAL SKIN CLOSURE STRIP1993-07-14

More clearances from Gainor Medical

K850100 — BLOOD LANCET1987-01-29
K850150 — ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED1985-02-21
K844305 — GAINOR MEDICAL FLOWMAX NEEDLES1984-11-30
K844306 — GAINOR MEDICAL SYRINGE1984-11-30
K840950 — ZINC OXIDE TAPE1984-10-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.