FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAF SINGLE-USE AEROSOL FILTER
K Number: K811203
·
Decision May 21, 1981
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
69
Review Days
20
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Basic Information
- Device Name
- SAF SINGLE-USE AEROSOL FILTER
- K Number
- K811203
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sorensen Research
- Date Received
- May 1, 1981
- Decision Date
- May 21, 1981
- Product Code
- GCY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Sorensen Research
| K Number | Device Name | ||
|---|---|---|---|
| K833674 | ACCURATE MEASUREMENT DEVICE KG-AMD | Jan 25, 1984 | Substantially Equivalent |
| K833673 | ACCURATE MEASUREMENT DEVICE EZ-AMD | Dec 29, 1983 | Substantially Equivalent |
| K833095 | TRANSDUCER DOME SD105 | Nov 3, 1983 | Substantially Equivalent |
| K833094 | TRANSDUCER DOME SD104 | Nov 3, 1983 | Substantially Equivalent |
| K833096 | TRANSDUCER DOME DS106 | Nov 3, 1983 | Substantially Equivalent |
| K832957 | FLOW-DIRECTED HEPARIN COATED THERMODIL | Sep 29, 1983 | Substantially Equivalent |
| K831506 | DISP. TRANSDUCER W/MONITORING KIT TRANS | Aug 12, 1983 | Substantially Equivalent |
| K831939 | TALL FLOOR STAND TFS-01 | Jul 19, 1983 | Substantially Equivalent |
| K831505 | THORACIC GAUGE #TG-60 -VACUUM REGULATOR | Jul 12, 1983 | Substantially Equivalent |
| K820706 | WATERLESS SEAL & VACUUM REGULATOR | Apr 9, 1982 | Substantially Equivalent |