510(k) K920883
K920883 is an FDA 510(k) premarket notification submitted by S.T.S Instruments for the device "HEMOSTAT, SURGICAL (VARIOUS TYPES)". The FDA issued a decision of Substantially Equivalent on March 13, 1992. The device falls under product code EMD (Hemostat, Surgical), a Class I device regulated under 21 CFR 872.4565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1992
- Date Received
- February 26, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostat, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type