SPECULITE— 510(k) K963391

Substantially Equivalent

Trylon Corp.

FDA 510(k) clearance K963391 for SPECULITE, Substantially Equivalent on 1997-12-12. Applicant: Trylon Corp..

Clearance details

Applicant: Trylon Corp.
Product code: Code MPU
Advisory panel: Obstetrics/Gynecology
Date received: 1996-08-28
Decision date: 1997-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monarch Beach, CA, US

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