FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUCTION CONNECTING TUBING
K Number: K914601
·
Decision Feb 7, 1992
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
12
Review Days
119
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Basic Information
- Device Name
- SUCTION CONNECTING TUBING
- K Number
- K914601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bemis Mfg. Co.
- Date Received
- October 11, 1991
- Decision Date
- February 7, 1992
- 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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| K953797 | SHARPS DISPOSAL CONTAINERS | Nov 27, 1995 | Substantially Equivalent |
| K950340 | IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS | Jun 2, 1995 | Substantially Equivalent |
| K941665 | SHARPS DISPOSAL CONTAINER/PHLEBOTOMY | May 23, 1994 | Substantially Equivalent |
| K931664 | SHARPS DISPOSABLE CONTAINERS | May 23, 1994 | Substantially Equivalent |
| K941664 | SHARP DISPOSAL CONTAINERS WALL SAFE | May 23, 1994 | Substantially Equivalent |
| K911576 | CHEMOTHERAPY CONTAINER | Jul 5, 1991 | Substantially Equivalent |