510(k) K843074

DISPOS. & SPONGE FORCEPS PEAN ARTERY by Greene International Corp. — Product Code GEN

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