FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILTER, TRANSFUSION BLOOD, INTERSEPT
K Number: K760222
·
Decision Aug 6, 1976
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
35
Applicant Total
56
Review Days
25
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Basic Information
- Device Name
- FILTER, TRANSFUSION BLOOD, INTERSEPT
- K Number
- K760222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Surgikos, Inc.
- Date Received
- July 12, 1976
- Decision Date
- August 6, 1976
- Product Code
- CAK
- 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 |
|---|---|---|---|
| CAK | Microfilter, Blood Transfusion | FDA class 2 | General Hospital |
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Other Clearances by Surgikos, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K875107 | HEALTH CARE EYE PROTECTION | Mar 21, 1988 | Substantially Equivalent |
| K874653 | STERILE SURGICAL SCRUB BRUSH | Dec 30, 1987 | Substantially Equivalent |
| K861441 | NEUTRALON SURGICAL GLOVES | May 30, 1986 | Substantially Equivalent |
| K852870 | BARRIER SURGICAL GOWN | Jul 23, 1985 | Substantially Equivalent |
| K822535 | CIDEX*DIALYZER DISINFECTING SOLUTION | Sep 30, 1982 | Substantially Equivalent |
| K820543 | BARRIER ANTIMICROBIAL INCISE DRAPE | Jul 22, 1982 | Substantially Equivalent |
| K820542 | SURGIKOS INCISE DRAPE | Jun 2, 1982 | Substantially Equivalent |
| K811871 | BACTERICIDAL INCISE DRAPE | Aug 20, 1981 | Substantially Equivalent |
| K810316 | SURGIKOS FACE MASK | Feb 23, 1981 | Substantially Equivalent |
| K801864 | BARRIER APERTURED DRAPE | Aug 20, 1980 | Substantially Equivalent |