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

STERILE LACERATION TRAY CAT. #749

K Number: K900479 · Decision Feb 13, 1990
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
31
Review Days
12

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
STERILE LACERATION TRAY CAT. #749
K Number
K900479
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Busse Hospital Disposables, Inc.
Date Received
February 1, 1990
Decision Date
February 13, 1990
Product Code
FSM
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
FSM Tray, Surgical, Instrument

Similar 510(k) Clearances

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

View all

Other Clearances by Busse Hospital Disposables, Inc.

K Number Device Name
K120002 I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
K093909 BUSSE SURGICAL DRAPES IV
K092212 BUSSE SURGICAL DRAPES III
K082297 BUSSE SURGICAL DRAPE
K073222 MODIFICATION TO:SPECIALTY NEEDLES
K070465 BUSSE EPIDURAL CATHETER
K063018 GLASS LOSS OF RESISTANCE SYRINGE
K061394 SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
K061570 I-STYLE BONE MARROW ASPIRATION NEEDLE
K052843 BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
Search all 31 clearances from Busse Hospital Disposables, Inc. →