FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRAPPED EYE SHIELD
K Number: K896172
·
Decision Nov 3, 1989
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
6
Review Days
9
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Basic Information
- Device Name
- STRAPPED EYE SHIELD
- K Number
- K896172
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Eye Garter Company, Inc.
- Date Received
- October 25, 1989
- Decision Date
- November 3, 1989
- 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 Eye Garter Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900941 | OMNIPATCH | May 21, 1990 | Substantially Equivalent |
| K896171 | EYE PATCH | Nov 3, 1989 | Substantially Equivalent |
| K880489 | CLEAR EYE GARTER SHIELD | Aug 8, 1988 | Substantially Equivalent |
| K880490 | BLUE PLASTIC EYE SHIELD | May 3, 1988 | Substantially Equivalent |
| K880675 | EASY SHIELD ADHESIVE BANDAGE | Apr 1, 1988 | Substantially Equivalent |