C-SECTION PACK— 510(k) K921730

Substantially Equivalent

Medikmark, Inc.

FDA 510(k) clearance K921730 for C-SECTION PACK, Substantially Equivalent on 1994-06-15. Applicant: Medikmark, Inc.. Device class: 1.

Clearance details

Applicant: Medikmark, Inc.
Product code: Code KOH
Device class: Class 1
Regulation: 21 CFR 884.4520
Advisory panel: Obstetrics/Gynecology
Date received: 1992-04-10
Decision date: 1994-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, 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.