Cleared Traditional

SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION

K911996 · International Technidyne Corp. · Hematology
Jul 1991
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K911996 is an FDA 510(k) clearance for the SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION, a Device, Bleeding Time (Class II — Special Controls, product code JCA), submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on July 17, 1991, 86 days after receiving the submission on April 22, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6100.

Submission Details

510(k) Number K911996 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1991
Decision Date July 17, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JCA — Device, Bleeding Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6100