510(k) K974594
K974594 is an FDA 510(k) premarket notification submitted by Titan Mfg., Inc. for the device "SEMKIN BIPOLAR FORCEP". The FDA issued a decision of Substantially Equivalent on June 24, 1998. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. Titan Mfg., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1998
- Date Received
- December 9, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type