FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEREGRINE PIC MINIPULATOR
K Number: K940392
·
Decision Aug 23, 1994
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
19
Review Days
209
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Basic Information
- Device Name
- PEREGRINE PIC MINIPULATOR
- K Number
- K940392
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Peregrine Surgical , Ltd.
- Date Received
- January 26, 1994
- Decision Date
- August 23, 1994
- Product Code
- KYG
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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| K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | Aug 4, 1998 | Substantially Equivalent |
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