FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE
K Number: K893958
·
Decision Oct 3, 1989
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
19
Review Days
124
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Basic Information
- Device Name
- BAXTER ACETONE-ALCOHOL PREP PADS, STERILE
- K Number
- K893958
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Span-America Medical Systems, Inc.
- Date Received
- June 1, 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 | Device Class | Medical Specialty |
|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | FDA unclassified | Unknown |
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Other Clearances by Span-America Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972486 | PRESSUREGUARD IV | Feb 20, 1998 | Substantially Equivalent |
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| K960188 | PRESSUREGUARD: SELECTCARE | Oct 2, 1996 | Substantially Equivalent |
| K961502 | LUBRICATING JELLY, LOW VISCOSITY | Jul 18, 1996 | Substantially Equivalent |
| K961159 | POWERED LOW AIR LOSS MATTRESS SYSTEM | Jun 14, 1996 | Substantially Equivalent |
| K960620 | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM | Apr 25, 1996 | Substantially Equivalent |
| K960189 | GEL-T CUSHION | Feb 7, 1996 | Substantially Equivalent |
| K954766 | PRESSURE GUARD ALTERNATING PRESSURE MATTRESS | Jan 11, 1996 | Substantially Equivalent |
| K953503 | PRESSUREGUARD IV | Oct 24, 1995 | Substantially Equivalent |
| K954117 | CUSTOMCARE SEATING SYSTEM | Oct 13, 1995 | Substantially Equivalent |