FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGIKOS FACE MASK
K Number: K810316
·
Decision Feb 23, 1981
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
56
Review Days
17
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Basic Information
- Device Name
- SURGIKOS FACE MASK
- K Number
- K810316
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Surgikos, Inc.
- Date Received
- February 6, 1981
- Decision Date
- February 23, 1981
- Product Code
- FXX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
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HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
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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 |
| K801864 | BARRIER APERTURED DRAPE | Aug 20, 1980 | Substantially Equivalent |
| K801863 | BARRIER TOWEL DRAPE | Aug 20, 1980 | Substantially Equivalent |