FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
K Number: K020999
·
Decision Jun 20, 2002
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
39
Applicant Total
7
Review Days
84
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Basic Information
- Device Name
- MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
- K Number
- K020999
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medefil, Inc.
- Date Received
- March 28, 2002
- Decision Date
- June 20, 2002
- Product Code
- NGT
- 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 |
|---|---|---|---|
| NGT | Saline, Vascular Access Flush | FDA class 2 | General Hospital |
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Other Clearances by Medefil, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121262 | MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY | Sep 20, 2012 | Substantially Equivalent |
| K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES | Feb 3, 2010 | Substantially Equivalent |
| K091583 | MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE | Jan 28, 2010 | Substantially Equivalent |
| K020996 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL | Jun 24, 2002 | Substantially Equivalent |
| K993518 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL | Jun 12, 2000 | Substantially Equivalent |
| K993515 | MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L | Feb 25, 2000 | Substantially Equivalent |