510(k) K895527

THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM by Quantitative Technologies, Inc. — Product Code FSM

K895527 is an FDA 510(k) premarket notification submitted by Quantitative Technologies, Inc. for the device "THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Quantitative Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
September 12, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type