FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEALTH CARE EYE PROTECTION
K Number: K875107
·
Decision Mar 21, 1988
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
56
Review Days
98
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Basic Information
- Device Name
- HEALTH CARE EYE PROTECTION
- K Number
- K875107
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgikos, Inc.
- Date Received
- December 14, 1987
- Decision Date
- March 21, 1988
- Product Code
- HOY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | FDA class 1 | Ophthalmic |
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Other Clearances by Surgikos, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K801863 | BARRIER TOWEL DRAPE | Aug 20, 1980 | Substantially Equivalent |