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510(k) K860796

DISPO-URETTE by Roland J. Zwick, Inc. — Product Code PCF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 8, 1986
Date Received: March 4, 1986
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Sampler, Endocervical
Device Class: Class II
Regulation Number: 884.1050
Review Panel: OB
Submission Type

Obtains tissue samples from the endocervical canal for histological analysis.