FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GAMMA RADIATION STERILIZED ALCOHOL PREP PADS
K Number: K860961
·
Decision Apr 9, 1986
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
5
Review Days
27
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Basic Information
- Device Name
- GAMMA RADIATION STERILIZED ALCOHOL PREP PADS
- K Number
- K860961
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- H & P Industries, Inc.
- Date Received
- March 13, 1986
- Decision Date
- April 9, 1986
- 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 H & P Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901217 | TRIA-SONIC ULTRA SOUND TRANSMISSION GEL | Jun 22, 1990 | Substantially Equivalent |
| K871169 | LUBRICATING JELLY | Apr 1, 1987 | Substantially Equivalent |
| K830394 | PROVIDONE-IODINE PREP-PADS & TOWELETTES | Apr 6, 1983 | Substantially Equivalent |
| K830393 | PROVIDONE-IODINE SWABSTICKS | Apr 6, 1983 | Substantially Equivalent |