FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESSURE TUBING AND ACCESSORIES
K Number: K922777
·
Decision Mar 22, 1994
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
10
Review Days
651
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Basic Information
- Device Name
- PRESSURE TUBING AND ACCESSORIES
- K Number
- K922777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arbor Technologies, Inc.
- Date Received
- June 9, 1992
- Decision Date
- March 22, 1994
- Product Code
- HIF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Arbor Technologies, Inc.
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|---|---|---|---|
| K960928 | SYRINGEFILTER | Apr 4, 1997 | Substantially Equivalent |
| K964283 | AUTOPRIME | Jan 22, 1997 | Substantially Equivalent |
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| K895859 | CONTAIN(TM) | Feb 7, 1991 | Substantially Equivalent |
| K902167 | CONTAIN(TM) LASER PLUME FILTER | Jan 4, 1991 | Substantially Equivalent |
| K890844 | MICROSEPT 60/20 | Jun 7, 1989 | Substantially Equivalent |
| K874505 | CONTAIN(TM) | May 20, 1988 | Substantially Equivalent |
| K864113 | CLYDE (TM) FILTRATION SYSTEM | Feb 4, 1987 | Substantially Equivalent |
| K863162 | VACU-GUARD | Aug 29, 1986 | Substantially Equivalent |