FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE ISOTONIC SALINE & STERILE WATER
K Number: K954442
·
Decision Dec 21, 1995
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
83
Applicant Total
11
Review Days
87
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Basic Information
- Device Name
- STERILE ISOTONIC SALINE & STERILE WATER
- K Number
- K954442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcare Custom Packaging, Inc.
- Date Received
- September 25, 1995
- Decision Date
- December 21, 1995
- Product Code
- JOL
- 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 |
|---|---|---|---|
| JOL | Catheter And Tip, Suction | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOL), ordered by most recent decision date.
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
FDA 510(k)
FDA Class 2
·General Hospital
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
FDA 510(k)
FDA Class 2
·General Hospital
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Medcare Custom Packaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | Jan 19, 1996 | Substantially Equivalent |
| K952759 | TOWEL PACK | Sep 29, 1995 | Substantially Equivalent |
| K950390 | URETHRAL CATHETERIZATION TRAY | May 30, 1995 | Substantially Equivalent |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Apr 10, 1995 | Substantially Equivalent |
| K951149 | SINGLE USE INSTRUMENT TRAY | Apr 6, 1995 | Unknown |
| K934732 | PELVIC EXAM TRAY | Dec 30, 1994 | Substantially Equivalent |
| K942000 | BURN DRESSING TRAY | May 20, 1994 | Unknown |
| K936261 | CATHETER INSERTION TRAY | Mar 10, 1994 | Unknown |
| K922179 | CATHETER INSERTION TRAY | Jul 2, 1993 | Unknown |
| K901856 | CUSTOM WOUND MANAGEMENT KITS AND TRAYS | Aug 1, 1990 | Unknown |