FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISCIENCE SURGICAL VISCOINJECTOR
K Number: K050716
·
Decision Apr 21, 2005
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
18
Applicant Total
2
Review Days
31
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Basic Information
- Device Name
- ISCIENCE SURGICAL VISCOINJECTOR
- K Number
- K050716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iscience Surgical Corporation
- Date Received
- March 21, 2005
- Decision Date
- April 21, 2005
- Product Code
- MRH
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | FDA class 2 | General Hospital |
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Other Clearances by Iscience Surgical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K041108 | ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA | Jun 22, 2004 | Substantially Equivalent |