FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AQUALUBE(TM)
K Number: K864556
·
Decision Dec 1, 1986
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
30
Review Days
12
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Basic Information
- Device Name
- AQUALUBE(TM)
- K Number
- K864556
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Parker Laboratories, Inc.
- Date Received
- November 19, 1986
- Decision Date
- December 1, 1986
- 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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FDA Class 1
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COLONGLIDE LUBRICANT
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FDA Class 1
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COLONGLIDE(R) LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
LUBE JELLY SURINGE
FDA 510(k)
FDA Class 1
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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
Other Clearances by Parker Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Aug 15, 2024 | Substantially Equivalent |
| K953673 | ECLIPSE PROBE COVER | Mar 14, 1996 | Substantially Equivalent |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | Feb 23, 1995 | Substantially Equivalent |
| K861239 | ACRYLIC SOLDER | Apr 17, 1986 | Substantially Equivalent |
| K855167 | DYNA SYSTEM | Mar 4, 1986 | Substantially Equivalent |
| K851895 | POLYGEL ULTRASOUND GEL | Sep 27, 1985 | Substantially Equivalent |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | Aug 9, 1985 | Substantially Equivalent |
| K841400 | NEURO PULSE | Jun 15, 1984 | Substantially Equivalent |
| K840548 | RESIL | Apr 17, 1984 | Substantially Equivalent |
| K831039 | COMPLUS VARIOUS FORMS | May 27, 1983 | Substantially Equivalent |