Cleared Traditional

STRUNG TELFA NON-ADHERENT SPONGE

K904514 · American Silk Sutures, Inc. · Neurology
Mar 1991
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K904514 is an FDA 510(k) clearance for the STRUNG TELFA NON-ADHERENT SPONGE, a Neurosurgical Paddie (Class II — Special Controls, product code HBA), submitted by American Silk Sutures, Inc. (Tamarac, US). The FDA issued a Cleared decision on March 27, 1991, 176 days after receiving the submission on October 2, 1990. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4700.

Submission Details

510(k) Number K904514 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1990
Decision Date March 27, 1991
Days to Decision 176 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code HBA — Neurosurgical Paddie
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4700

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