BIOSTRIP STERILE WOUND CLOSURE STRIP— 510(k) K946321

Name: FDA 510(k) clearance K946321
Creator: U.S. Food and Drug Administration
Published: 1995-01-12

Substantially Equivalent

Cornelia Damsky, Inc.

FDA 510(k) clearance K946321 for BIOSTRIP STERILE WOUND CLOSURE STRIP, Substantially Equivalent on 1995-01-12. Applicant: Cornelia Damsky, Inc.. Device class: 1.

Clearance details

Applicant: Cornelia Damsky, Inc.
Product code: Code FPX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1994-12-28
Decision date: 1995-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

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