THE D & C PAD-SAC— 510(k) K862297

Substantially Equivalent

Nu-Gyn-Tek, Inc.

FDA 510(k) clearance K862297 for THE D & C PAD-SAC, Substantially Equivalent on 1986-07-07. Applicant: Nu-Gyn-Tek, Inc.. Device class: 1.

Clearance details

Applicant: Nu-Gyn-Tek, Inc.
Product code: Code HCY
Device class: Class 1
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1986-06-17
Decision date: 1986-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakfield, NY, US

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