FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERI-LUB LUBRICATION GEL
K Number: K944969
·
Decision Feb 27, 1995
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
3
Review Days
139
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Basic Information
- Device Name
- STERI-LUB LUBRICATION GEL
- K Number
- K944969
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Horizon Medical, Inc.
- Date Received
- October 11, 1994
- Decision Date
- February 27, 1995
- Product Code
- KMJ
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMJ | Lubricant, Patient | FDA class 1 | General Hospital |
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