510(k) K920298
K920298 is an FDA 510(k) premarket notification submitted by Falcon Instruments, Inc. for the device "DISPOSABLE HEMOSTATS". The FDA issued a decision of Substantially Equivalent on August 11, 1992. The device falls under product code HRQ (Hemostat), a Class I device regulated under 21 CFR 878.4800. Falcon Instruments, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1992
- Date Received
- January 22, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostat
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type