DEROYAL INDUSTRIES INFANT HEEL WARMER— 510(k) K954716

Name: FDA 510(k) clearance K954716
Creator: U.S. Food and Drug Administration
Published: 1996-01-11

Substantially Equivalent

Debusk Knitting Mills, Div. Deroyal Industries

FDA 510(k) clearance K954716 for DEROYAL INDUSTRIES INFANT HEEL WARMER, Substantially Equivalent on 1996-01-11. Applicant: Debusk Knitting Mills, Div. Deroyal Industries. Device class: 1.

Clearance details

Applicant: Debusk Knitting Mills, Div. Deroyal Industries
Product code: Code MPO
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 1995-10-13
Decision date: 1996-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

Download summary PDF View on FDA.gov ↗

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