FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLASTIC OVERLAYS
K Number: K911374
·
Decision Jul 26, 1991
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
1
Applicant Total
1
Review Days
120
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PLASTIC OVERLAYS
- K Number
- K911374
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1650
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- National Reading Service
- Date Received
- March 28, 1991
- Decision Date
- July 26, 1991
- Product Code
- HKW
- 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 |
|---|---|---|---|
| HKW | Prism, Bar, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKW), ordered by most recent decision date.
View all