FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INAMED DEVELOPMENT ASPIRATION TIP
K Number: K931548
·
Decision Jan 10, 1994
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
7
Review Days
287
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Basic Information
- Device Name
- INAMED DEVELOPMENT ASPIRATION TIP
- K Number
- K931548
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Inamed Development Co.
- Date Received
- March 29, 1993
- Decision Date
- January 10, 1994
- Product Code
- GCX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | FDA class 2 | General Hospital |
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Other Clearances by Inamed Development Co.
| K Number | Device Name | ||
|---|---|---|---|
| K904265 | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER | Mar 6, 1991 | Substantially Equivalent |
| K901742 | INAMED SMALL DRAIN SYSTEM | May 7, 1990 | 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 |