FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEOSPORIN SCAR SOLUTION
K Number: K024160
·
Decision Mar 17, 2003
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
50
Review Days
90
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Basic Information
- Device Name
- NEOSPORIN SCAR SOLUTION
- K Number
- K024160
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4025
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Warner-Lambert Co.
- Date Received
- December 17, 2002
- Decision Date
- March 17, 2003
- Product Code
- MDA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Warner-Lambert Co.
| K Number | Device Name | ||
|---|---|---|---|
| K893452 | EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM | Jun 22, 1989 | Substantially Equivalent |
| K870584 | O.P.T.(TM) OVULATION PREDICTION TEST | Nov 25, 1987 | Substantially Equivalent |
| K861510 | MULTILUMEN VIAPIC CENTRAL LINE CATHETER | Jun 9, 1986 | Substantially Equivalent |
| K852689 | GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK | Aug 19, 1985 | Substantially Equivalent |
| K852967 | GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK | Aug 19, 1985 | Substantially Equivalent |
| K852843 | GENERAL DIAGNOSTICS COAG-A-MATE XC | Aug 13, 1985 | Substantially Equivalent |
| K852889 | GENERAL DIAGNOSTICS RAPID E. COLI TEST | Jul 23, 1985 | Substantially Equivalent |
| K850409 | GEN. DIAG. CHROMOSTRATE REF. PLASMA | May 8, 1985 | Substantially Equivalent |
| K850412 | GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY | May 8, 1985 | Substantially Equivalent |
| K850486 | GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY | May 8, 1985 | Substantially Equivalent |