FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSBON PERSONAL LUBRICANT
K Number: K896207
·
Decision Dec 1, 1989
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
48
Applicant Total
4
Review Days
36
Basic Information
- Device Name
- OSBON PERSONAL LUBRICANT
- K Number
- K896207
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- OSBON MEDICAL SYSTEMS, LTD.
- Date Received
- October 26, 1989
- Decision Date
- December 1, 1989
- 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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