FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROFERA SURGICAL SPEAR
K Number: K974313
·
Decision Mar 2, 1998
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
7
Review Days
105
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Basic Information
- Device Name
- HYDROFERA SURGICAL SPEAR
- K Number
- K974313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hydrofera, LLC
- Date Received
- November 17, 1997
- Decision Date
- March 2, 1998
- 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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| K130670 | HYDROFERA BLUE PU BACTERIOSTATIC DRESSING | Jan 2, 2014 | Substantially Equivalent |
| K023138 | HYDROFERA BACTERIOSTATIC WOUND DRESSING | Jan 17, 2003 | Substantially Equivalent |
| K013462 | HYDROFERA BACTERIOSTATIC WOUND DRESSING | Jan 11, 2002 | Substantially Equivalent |
| K983276 | HYDROFERA BACTERISTATIC NASAL DRESSING | Sep 14, 1999 | Substantially Equivalent |
| K974316 | HYDROFERA FEMORAL WICK | Feb 13, 1998 | Substantially Equivalent |