FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDLINE BAND BAGS AND EQUIPMENT COVERS
K Number: K032065
·
Decision Sep 22, 2003
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
14
Applicant Total
238
Review Days
81
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Basic Information
- Device Name
- MEDLINE BAND BAGS AND EQUIPMENT COVERS
- K Number
- K032065
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medline Industries, Inc.
- Date Received
- July 3, 2003
- Decision Date
- September 22, 2003
- Product Code
- MMP
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| MMP | Cover, Barrier, Protective | FDA class 2 | General, Plastic Surgery |
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