LAMINARIA JAPONICA CERVICAL DILATOR— 510(k) K833068

Substantially Equivalent

Medi-Spec

FDA 510(k) clearance K833068 for LAMINARIA JAPONICA CERVICAL DILATOR, Substantially Equivalent on 1984-02-04. Applicant: Medi-Spec. Device class: 2.

Clearance details

Applicant: Medi-Spec
Product code: Code HDY
Device class: Class 2
Regulation: 21 CFR 884.4260
Advisory panel: Obstetrics/Gynecology
Date received: 1983-09-08
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K011512 — MMODIFICATION TO LAMINARIA2001-07-09
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K892220 — LAMINARIA TENT1989-06-14

More clearances from Medi-Spec

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K801554 — STERILE CAST PADDING1980-08-04
K800404 — MEDSPEC OPERATIVE OPTHALMIC KIT1980-04-24
K800490 — STERILE DRESSING PACK1980-03-12

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