FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
USE OF TWEEN 80 AS A WETTING AGENT ON
K Number: K832802
·
Decision Dec 29, 1983
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
59
Review Days
133
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Basic Information
- Device Name
- USE OF TWEEN 80 AS A WETTING AGENT ON
- K Number
- K832802
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Bentley
- Date Received
- August 18, 1983
- Decision Date
- December 29, 1983
- Product Code
- DTN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by American Bentley
| K Number | Device Name | ||
|---|---|---|---|
| K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | Feb 12, 1988 | Substantially Equivalent |
| K873923 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Nov 6, 1987 | Substantially Equivalent |
| K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | Sep 1, 1987 | Substantially Equivalent |
| K870804 | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 | Sep 1, 1987 | Substantially Equivalent |
| K872133 | OXYGENATOR MODEL NO. BENTLEY 5 PLUS | Aug 24, 1987 | Substantially Equivalent |
| K870911 | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY | May 29, 1987 | Substantially Equivalent |
| K870269 | ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 | Mar 9, 1987 | Substantially Equivalent |
| K863249 | OXYGENATOR MODEL NO. BENTLEY-10 PLUS | Oct 20, 1986 | Substantially Equivalent |
| K861641 | HEPARIN-COATED EXTRACORPOREAL CIRCUITS | Sep 29, 1986 | Substantially Equivalent |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | Jul 15, 1986 | Substantially Equivalent |