STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)— 510(k) K960738

Name: FDA 510(k) clearance K960738
Creator: U.S. Food and Drug Administration
Published: 1997-05-06

Substantially Equivalent

Engineered Custom Mfg., Inc.

FDA 510(k) clearance K960738 for STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H), Substantially Equivalent on 1997-05-06. Applicant: Engineered Custom Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Engineered Custom Mfg., Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1996-02-23
Decision date: 1997-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield, NJ, US

Download summary PDF View on FDA.gov ↗

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