FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
K-Y LUBRICATING JELLY
K Number: K810310
·
Decision Apr 21, 1981
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
206
Review Days
75
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Basic Information
- Device Name
- K-Y LUBRICATING JELLY
- K Number
- K810310
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- February 5, 1981
- Decision Date
- April 21, 1981
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMJ), ordered by most recent decision date.
Lubricating Jelly
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COLONGLIDE LUBRICANT
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COLONGLIDE(R) LUBRICANT
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FDA Class 1
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LUBE JELLY SURINGE
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DUKAL LUBRICATING JELLY
FDA 510(k)
FDA Class 1
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STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
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