FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GOOD LUBRICATIONS
K Number: K020586
·
Decision Jan 24, 2003
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
17
Review Days
336
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Basic Information
- Device Name
- GOOD LUBRICATIONS
- K Number
- K020586
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biofilm, Inc.
- Date Received
- February 22, 2002
- Decision Date
- January 24, 2003
- 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
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FDA Class 1
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|---|---|---|---|
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| K213671 | Astroglide Sensual Strawberry Personal Lubricant | Mar 3, 2022 | Substantially Equivalent |
| K210242 | Astroglide X Silicone Personal Lubricant | Apr 28, 2021 | Substantially Equivalent |
| K200239 | Astroglide Organix Gel | Nov 13, 2020 | Substantially Equivalent |
| K200114 | Astroglide Organix Liquid | Oct 13, 2020 | Substantially Equivalent |
| K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Aug 30, 2017 | Substantially Equivalent |
| K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | Feb 10, 2017 | Substantially Equivalent |
| K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | Jan 9, 2015 | Substantially Equivalent |