510(k) K850542
K850542 is an FDA 510(k) premarket notification submitted by International Technidyne Corp. for the device "SURGICUTT - BLEEDING TIME DEVICE". The FDA issued a decision of Substantially Equivalent on March 1, 1985. 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
- March 1, 1985
- Date Received
- February 11, 1985
- 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