FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MSP OPHTHALMIC (EYE SPUD)
K Number: K931449
·
Decision Aug 31, 1993
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
1
Applicant Total
2
Review Days
161
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Basic Information
- Device Name
- MSP OPHTHALMIC (EYE SPUD)
- K Number
- K931449
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Sterile Products, Inc.
- Date Received
- March 23, 1993
- Decision Date
- August 31, 1993
- Product Code
- HNA
- 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 |
|---|---|---|---|
| HNA | Spud, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNA), ordered by most recent decision date.
View allOther Clearances by Medical Sterile Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993122 | MSP M/K BLADE | Mar 16, 2000 | Substantially Equivalent |