FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PDI STERILE LUBRICATING JELLY
K Number: K974768
·
Decision Jan 16, 1998
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
9
Review Days
25
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Basic Information
- Device Name
- PDI STERILE LUBRICATING JELLY
- K Number
- K974768
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nice-Pak Products, Inc.
- Date Received
- December 22, 1997
- Decision Date
- January 16, 1998
- 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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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
Other Clearances by Nice-Pak Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K840342 | PDI PREPMASTER WET PACK PATIENT PREP KIT | Mar 27, 1984 | Substantially Equivalent |
| K840343 | PDI PREPMASTER WET PACK VAGINAL-X21477 | Mar 27, 1984 | Substantially Equivalent |
| K840344 | PDI PREPMASTER WET PACK MINOR PROCEDURE | Mar 26, 1984 | Substantially Equivalent |
| K833549 | PDI SURGICAL SCRUB/BRUSH T150-70 | Nov 28, 1983 | Substantially Equivalent |
| K810337 | PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 | Feb 26, 1981 | Substantially Equivalent |
| K781539 | ISO-CARE KIT | Nov 3, 1978 | Substantially Equivalent |
| K780279 | ICE-PAK, PDI | Apr 10, 1978 | Substantially Equivalent |
| K780400 | DEN-Z-ORB | Mar 27, 1978 | Substantially Equivalent |