510(k) K900479

STERILE LACERATION TRAY CAT. #749 by Busse Hospital Disposables, Inc. — Product Code FSM

K900479 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "STERILE LACERATION TRAY CAT. #749". The FDA issued a decision of Substantially Equivalent on February 13, 1990. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1990
Date Received
February 1, 1990
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