510(k) K864139

RANFAC CUT BIOPSY NEEDLE by Ranfac, Corp. — Product Code GAA

K864139 is an FDA 510(k) premarket notification submitted by Ranfac, Corp. for the device "RANFAC CUT BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on November 5, 1986. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Ranfac, Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1986
Date Received
October 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type