INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX— 510(k) K100517

Substantially Equivalent

Instrumed International, Inc.

FDA 510(k) clearance K100517 for INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX, Substantially Equivalent on 2010-04-29. Applicant: Instrumed International, Inc.. Device class: 2.

Clearance details

Applicant: Instrumed International, Inc.
Product code: Code HDA
Device class: Class 2
Regulation: 21 CFR 884.4400
Advisory panel: Obstetrics/Gynecology
Date received: 2010-02-23
Decision date: 2010-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, 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.