FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INAMED SMALL DRAIN SYSTEM
K Number: K901742
·
Decision May 7, 1990
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
7
Review Days
20
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Basic Information
- Device Name
- INAMED SMALL DRAIN SYSTEM
- K Number
- K901742
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Inamed Development Co.
- Date Received
- April 17, 1990
- Decision Date
- May 7, 1990
- 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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Other Clearances by Inamed Development Co.
| K Number | Device Name | ||
|---|---|---|---|
| K931548 | INAMED DEVELOPMENT ASPIRATION TIP | Jan 10, 1994 | Substantially Equivalent |
| K904265 | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER | Mar 6, 1991 | Substantially Equivalent |
| K901764 | INAMED CONVERTIBLE DRAIN SYSTEM | May 7, 1990 | Substantially Equivalent |
| K894618 | INAMED RHEMO-D (TM) DILATOR | Jan 18, 1990 | Substantially Equivalent |
| K896491 | INAMED CLOSED-WOUND DRAIN SYSTEM | Jan 8, 1990 | Substantially Equivalent |
| K894073 | INAMED PRO-TEC SILICONE SURGICAL GLOVES | Sep 18, 1989 | Substantially Equivalent |