ELAN-E DISPOSALBE DRAPE— 510(k) K882494

Name: FDA 510(k) clearance K882494
Creator: U.S. Food and Drug Administration
Published: 1988-07-08

Substantially Equivalent

Dermacare Products, Inc.

FDA 510(k) clearance K882494 for ELAN-E DISPOSALBE DRAPE, Substantially Equivalent on 1988-07-08. Applicant: Dermacare Products, Inc.. Device class: 2.

Clearance details

Applicant: Dermacare Products, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1988-06-16
Decision date: 1988-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KT, US

Download summary PDF View on FDA.gov ↗

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K882421 — INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE1988-06-30
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K863279 — SURGI-TEK TUBE POSITIONER1986-09-09
K863280 — DERMAMARKER1986-09-09
K863278 — SURGI-WIPES1986-09-02

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