CRYOPETTE— 510(k) K100596

Substantially Equivalent

Mid-Atlantic Diagnostics, Inc.

FDA 510(k) clearance K100596 for CRYOPETTE, Substantially Equivalent on 2010-12-06. Applicant: Mid-Atlantic Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Mid-Atlantic Diagnostics, Inc.
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2010-03-02
Decision date: 2010-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy Spring, MD, 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.