FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
K Number: K980400
·
Decision Apr 30, 1998
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
19
Review Days
87
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Basic Information
- Device Name
- PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
- K Number
- K980400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peregrine Surgical , Ltd.
- Date Received
- February 2, 1998
- Decision Date
- April 30, 1998
- 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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