DISPOSABLE EMISSIONS BARRIER LASER DRAPE— 510(k) K903346

Name: FDA 510(k) clearance K903346
Creator: U.S. Food and Drug Administration
Published: 1990-12-05

Substantially Equivalent

Wave-Form Systems, Inc.

FDA 510(k) clearance K903346 for DISPOSABLE EMISSIONS BARRIER LASER DRAPE, Substantially Equivalent on 1990-12-05. Applicant: Wave-Form Systems, Inc.. Device class: 2.

Clearance details

Applicant: Wave-Form Systems, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1990-07-25
Decision date: 1990-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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