FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPHTHALMIC DRESSING TRAY
K Number: K790909
·
Decision Aug 3, 1979
Classifications
1
FEI Numbers
106
Registration Numbers
107
Same Product Code
31
Applicant Total
1
Review Days
81
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Basic Information
- Device Name
- OPHTHALMIC DRESSING TRAY
- K Number
- K790909
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Pent-Cal, Inc.
- Date Received
- May 14, 1979
- Decision Date
- August 3, 1979
- 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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