FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
K Number: K003867
·
Decision Mar 9, 2001
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
230
Applicant Total
8
Review Days
87
Basic Information
- Device Name
- EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
- K Number
- K003867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIOFILM, INC.
- Date Received
- December 12, 2000
- Decision Date
- March 9, 2001
- Product Code
- NUC
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| NUC | Lubricant, Personal | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by BIOFILM, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | Jan 9, 2015 | Substantially Equivalent |
| K140590 | ASTROGLIDE SENSUAL STRAWBERRY | Oct 30, 2014 | Substantially Equivalent |
| K141581 | ASTROGLIDE NATURAL | Aug 6, 2014 | Substantially Equivalent |
| K072647 | GLYCERIN & PARABEN FREE ASTROGLIDE | Jan 25, 2008 | Substantially Equivalent |
| K041432 | ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT | Nov 30, 2004 | Substantially Equivalent |
| K020586 | GOOD LUBRICATIONS | Jan 24, 2003 | Substantially Equivalent |
| K935299 | ASTROGLIDE | Feb 18, 1994 | Substantially Equivalent |