510(k) K843074
K843074 is an FDA 510(k) premarket notification submitted by Greene International Corp. for the device "DISPOS. & SPONGE FORCEPS PEAN ARTERY". The FDA issued a decision of Substantially Equivalent on August 17, 1984. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Greene International Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1984
- Date Received
- August 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type