FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL SUCTION INSTRUMENTS-DISPOS.
K Number: K812845
·
Decision Nov 16, 1981
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
127
Review Days
38
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Basic Information
- Device Name
- SURGICAL SUCTION INSTRUMENTS-DISPOS.
- K Number
- K812845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Abco Dealers, Inc.
- Date Received
- October 9, 1981
- Decision Date
- November 16, 1981
- 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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|---|---|---|---|
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| K872875 | STRETCH GAUZE BANDAGES | Sep 4, 1987 | Substantially Equivalent |
| K872874 | MICROSCOPE COVER GLASSES | Aug 10, 1987 | Substantially Equivalent |
| K872797 | NON-SKID SHOE COVERS | Aug 4, 1987 | Substantially Equivalent |
| K871465 | THERMOMETER SHEATHS | May 11, 1987 | Substantially Equivalent |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Aug 1, 1986 | Substantially Equivalent |
| K862111 | ARMBOARDS, REUSABLE AND DISPOSABLE | Jul 8, 1986 | Substantially Equivalent |