FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTOME
K Number: K771711
·
Decision Sep 28, 1977
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
4
Review Days
16
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Basic Information
- Device Name
- BIOTOME
- K Number
- K771711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Berkeley Bio-Engineering
- Date Received
- September 12, 1977
- Decision Date
- September 28, 1977
- Product Code
- HQE
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
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