COLPO-MASTER— 510(k) K073053

Name: FDA 510(k) clearance K073053
Creator: U.S. Food and Drug Administration
Published: 2007-11-15

Substantially Equivalent

United Products & Instruments, Inc.

FDA 510(k) clearance K073053 for COLPO-MASTER, Substantially Equivalent on 2007-11-15. Applicant: United Products & Instruments, Inc.. Device class: 2.

Clearance details

Applicant: United Products & Instruments, Inc.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2007-10-30
Decision date: 2007-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

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