FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE SALINE SOLUTION
K Number: K854155
·
Decision Dec 10, 1985
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
41
Review Days
60
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Basic Information
- Device Name
- STERILE SALINE SOLUTION
- K Number
- K854155
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- I M, Inc.
- Date Received
- October 11, 1985
- Decision Date
- December 10, 1985
- 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
FDA 510(k)
FDA Class 1
·General Hospital
COLONGLIDE LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
COLONGLIDE(R) LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
LUBE JELLY SURINGE
FDA 510(k)
FDA Class 1
·General Hospital
DUKAL LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by I M, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914600 | NEUROLOGICAL SPONGE | Dec 30, 1992 | Substantially Equivalent |
| K892389 | BIOPSY KIT | Jul 17, 1989 | Unknown |
| K881363 | SYRINGE PREFILLED WITH WATER | Jun 23, 1988 | Substantially Equivalent |
| K880753 | UMBILICAL CORD CLAMP | Apr 27, 1988 | Substantially Equivalent |
| K872741 | NUTRIPUMP | Oct 20, 1987 | Substantially Equivalent |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | May 8, 1987 | Substantially Equivalent |
| K863785 | MAKLER CATHETER | Dec 11, 1986 | Substantially Equivalent |
| K853287 | HUBOUT | Oct 17, 1985 | Substantially Equivalent |
| K853288 | FEEDING UNITS & TUBES | Oct 4, 1985 | Substantially Equivalent |
| K853286 | STAPLE REMOVER | Aug 21, 1985 | Substantially Equivalent |