FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER
K Number: K960426
·
Decision Mar 21, 1996
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
16
Applicant Total
63
Review Days
52
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Basic Information
- Device Name
- MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER
- K Number
- K960426
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Components, Inc.
- Date Received
- January 29, 1996
- Decision Date
- March 21, 1996
- Product Code
- GBW
- 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 |
|---|---|---|---|
| GBW | Catheter, Peritoneal | FDA class 1 | General, Plastic Surgery |
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