510(k) K911996

SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION by International Technidyne Corp. — Product Code JCA

K911996 is an FDA 510(k) premarket notification submitted by International Technidyne Corp. for the device "SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION". The FDA issued a decision of Substantially Equivalent on July 17, 1991. The device falls under product code JCA (Device, Bleeding Time), a Class II device regulated under 21 CFR 864.6100. International Technidyne Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1991
Date Received
April 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Bleeding Time
Device Class
Class II
Regulation Number
864.6100
Review Panel
HE
Submission Type