FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERFORATED SOAKING TUBE
K Number: K874596
·
Decision Dec 2, 1987
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
7
Applicant Total
4
Review Days
23
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Basic Information
- Device Name
- PERFORATED SOAKING TUBE
- K Number
- K874596
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Specialty Medical Products Co.
- Date Received
- November 9, 1987
- Decision Date
- December 2, 1987
- Product Code
- GBQ
- 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 |
|---|---|---|---|
| GBQ | Catheter, Continuous Irrigation | FDA class 1 | General, Plastic Surgery |
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