FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CARBON LIGHTS HAND SURGERY TABLE

K Number: K944779 · Decision Oct 14, 1994
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
60
Applicant Total
5
Review Days
17

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
CARBON LIGHTS HAND SURGERY TABLE
K Number
K944779
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4950
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Allen Medical Systems, Inc.
Date Received
September 27, 1994
Decision Date
October 14, 1994
Product Code
FWZ
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FWZ Operating Room Accessories Table Tray

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (FWZ), ordered by most recent decision date.

View all

Other Clearances by Allen Medical Systems, Inc.

K Number Device Name
K971988 ALLEN, ULTRA AND SMART SOCKETS
K964273 DURA-BOARD ARMBOARD
K960027 HIGH VOLUME I.V. & IRRIGATION TOWER
K921168 ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000