SAFETEX CERVICAL SCRAPER (PLASTIC)— 510(k) K983428

Name: FDA 510(k) clearance K983428
Creator: U.S. Food and Drug Administration
Published: 1998-11-16

Substantially Equivalent

Andwin Scientific

FDA 510(k) clearance K983428 for SAFETEX CERVICAL SCRAPER (PLASTIC), Substantially Equivalent on 1998-11-16. Applicant: Andwin Scientific. Device class: 2.

Clearance details

Applicant: Andwin Scientific
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1998-09-29
Decision date: 1998-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodland Hills, CA, US

Download summary PDF View on FDA.gov ↗

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