MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT— 510(k) K893436

Name: FDA 510(k) clearance K893436
Creator: U.S. Food and Drug Administration
Published: 1989-07-14

Substantially Equivalent

Pioneering Technologies, Inc.

FDA 510(k) clearance K893436 for MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT, Substantially Equivalent on 1989-07-14. Applicant: Pioneering Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Pioneering Technologies, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1989-05-03
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, 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.