FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSPEARS
K Number: K780257
·
Decision Feb 23, 1978
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
4
Review Days
8
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Basic Information
- Device Name
- MICROSPEARS
- K Number
- K780257
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Sparta Instrument Corp.
- Date Received
- February 15, 1978
- Decision Date
- February 23, 1978
- Product Code
- HOZ
- 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 |
|---|---|---|---|
| HOZ | Sponge, Ophthalmic | FDA class 2 | Ophthalmic |
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