FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEROMA-CATH CLOSE DRAINAGE SYSTEM
K Number: K905733
·
Decision Jan 28, 1991
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
4
Review Days
35
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Basic Information
- Device Name
- SEROMA-CATH CLOSE DRAINAGE SYSTEM
- K Number
- K905733
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Dawn Medical
- Date Received
- December 24, 1990
- Decision Date
- January 28, 1991
- Product Code
- GCY
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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