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

MINI-DIAMOND KNIFE

K Number: K893033 · Decision May 26, 1989
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
25
Applicant Total
1
Review Days
32

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
MINI-DIAMOND KNIFE
K Number
K893033
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
L.A.B. Instruments
Date Received
April 24, 1989
Decision Date
May 26, 1989
Product Code
GDX
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
GDX Scalpel, One-Piece

Similar 510(k) Clearances

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

View all