FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE

K Number: K894791 · Decision Oct 3, 1989
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
19
Review Days
67

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
BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE
K Number
K894791
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Span-America Medical Systems, Inc.
Date Received
July 28, 1989
Decision Date
October 3, 1989
Product Code
LKB
Advisory Committee
Unknown
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
LKB Pad, Alcohol, Device Disinfectant

Similar 510(k) Clearances

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

View all

Other Clearances by Span-America Medical Systems, Inc.

K Number Device Name
K972486 PRESSUREGUARD IV
K973169 PRESSURE GUARD SITE SELECT (A)
K960188 PRESSUREGUARD: SELECTCARE
K961502 LUBRICATING JELLY, LOW VISCOSITY
K961159 POWERED LOW AIR LOSS MATTRESS SYSTEM
K960620 PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
K960189 GEL-T CUSHION
K954766 PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
K953503 PRESSUREGUARD IV
K954117 CUSTOMCARE SEATING SYSTEM
Search all 19 clearances from Span-America Medical Systems, Inc. →