ENCOMPAS COMFORT BLOCK # 0B-10— 510(k) K933537

Name: FDA 510(k) clearance K933537
Creator: U.S. Food and Drug Administration
Published: 1994-04-08

Substantially Equivalent

Encompas Unlimited, Inc.

FDA 510(k) clearance K933537 for ENCOMPAS COMFORT BLOCK # 0B-10, Substantially Equivalent on 1994-04-08. Applicant: Encompas Unlimited, Inc.. Device class: 1.

Clearance details

Applicant: Encompas Unlimited, Inc.
Product code: Code MNK
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-07-21
Decision date: 1994-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tierra Verde, FL, US

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