DELPORE SKIN CLOSURE— 510(k) K952947

Substantially Equivalent

Bitco Intl.

FDA 510(k) clearance K952947 for DELPORE SKIN CLOSURE, Substantially Equivalent on 1995-07-24. Applicant: Bitco Intl.. Device class: 1.

Clearance details

Applicant: Bitco Intl.
Product code: Code FPX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1995-06-26
Decision date: 1995-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mclean, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPX

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K952702 — DERMA SEAL1995-06-28
K946321 — BIOSTRIP STERILE WOUND CLOSURE STRIP1995-01-12
K931005 — DUKAL SKIN CLOSURE STRIP1993-07-14
K921775 — SPYROFLEX WOUND CLOSURES1992-05-19

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