FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
K Number: K880647
·
Decision Apr 1, 1988
Classifications
1
FEI Numbers
106
Registration Numbers
107
Same Product Code
31
Applicant Total
278
Review Days
45
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Basic Information
- Device Name
- ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
- K Number
- K880647
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- February 16, 1988
- Decision Date
- April 1, 1988
- Product Code
- HOX
- 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 |
|---|---|---|---|
| HOX | Chart, Visual Acuity | FDA class 1 | Ophthalmic |
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