FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSPEARS
K Number: K896084
·
Decision Nov 2, 1989
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
7
Review Days
14
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Basic Information
- Device Name
- MICROSPEARS
- K Number
- K896084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Sparta Surgical Corp.
- Date Received
- October 19, 1989
- Decision Date
- November 2, 1989
- 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 |
Similar 510(k) Clearances
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Other Clearances by Sparta Surgical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K965187 | SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD | Aug 1, 1997 | Substantially Equivalent |
| K945313 | SPARTA HYDROGEL WOUND DRESSING | Jan 12, 1995 | Substantially Equivalent |
| K922729 | SPARTA WET DRESSING, SODIUM CHLORIDE | Nov 23, 1992 | Substantially Equivalent for Some Indications |
| K905384 | DAVID SIMMONDS ANESTHESIA EXTENSION TUBES | Mar 22, 1991 | Substantially Equivalent |
| K905240 | VESSELOOPS | Feb 6, 1991 | Substantially Equivalent |
| K896085 | SURGI-BRUSH | Nov 8, 1989 | Substantially Equivalent |