FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLEURAL DRAINAGE RESERVOIR
K Number: K820765
·
Decision Apr 15, 1982
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
12
Review Days
24
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Basic Information
- Device Name
- PLEURAL DRAINAGE RESERVOIR
- K Number
- K820765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Innovative Surgical Products, Inc.
- Date Received
- March 22, 1982
- Decision Date
- April 15, 1982
- 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 Innovative Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843041 | HESLIN DISPOS. TUBING SET | Nov 21, 1984 | Substantially Equivalent |
| K840693 | DISPOSABLE SCLERAL GLOBE PLUG | May 22, 1984 | Substantially Equivalent |
| K840695 | PHACOEMULSIFICATION KITS | May 22, 1984 | Substantially Equivalent |
| K840694 | LENS INSERTION GLIDE | May 9, 1984 | Substantially Equivalent |
| K841072 | IRRIGATION, ASPIRATION TUBING SETS | Mar 29, 1984 | Substantially Equivalent |
| K832235 | DISPOSABLE VITRECTOMY HANDPIECE | Sep 29, 1983 | Substantially Equivalent |
| K821496 | DISPOSABLE IRRIGA/ASPIR. SYSTEM | Jun 22, 1982 | Substantially Equivalent |
| K820680 | DISPOSABLE TUBING SETS | Apr 9, 1982 | Substantially Equivalent |
| K802973 | ISPVAC TM | Dec 19, 1980 | Substantially Equivalent |
| K801350 | ACUVAC(TM) SUCTION RESERVOIR 400CC AND | Jul 14, 1980 | Substantially Equivalent |