FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
E-Z LUBRICATING JELLY
K Number: K041060
·
Decision May 7, 2004
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
11
Review Days
14
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Basic Information
- Device Name
- E-Z LUBRICATING JELLY
- K Number
- K041060
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chester Labs, Inc.
- Date Received
- April 23, 2004
- Decision Date
- May 7, 2004
- Product Code
- KMJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
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.
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LUBE JELLY SURINGE
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DUKAL LUBRICATING JELLY
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STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Chester Labs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001705 | STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF | Jun 29, 2000 | Substantially Equivalent |
| K001593 | MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL | Jun 14, 2000 | Substantially Equivalent |
| K944599 | GRAHAM-FIELD CONDUCTIVE ECG SPRAY | May 7, 1996 | Substantially Equivalent |
| K944598 | GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL | May 7, 1996 | Substantially Equivalent |
| K944600 | GRAHAM-FIELD SALINE ELECTROLYTE GEL | Nov 20, 1995 | Substantially Equivalent |
| K944597 | GRAHAM-FIELD ULTRASOUND SCANNING GEL | Jun 21, 1995 | Substantially Equivalent |
| K944596 | GRAHAM-FIELD ULTRASOUND LOTION | Jun 7, 1995 | Substantially Equivalent |
| K940254 | BIOSHIELD BLUE POWDER FREE GLOVE | Mar 23, 1994 | Substantially Equivalent |
| K940256 | BIOSHIELD BLUE LATEX GLOVES | Mar 23, 1994 | Substantially Equivalent |
| K841871 | LIQUA-SONIC GEL | Mar 14, 1985 | Substantially Equivalent |