FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANIS IRRIGATING SPATULA
K Number: K810937
·
Decision May 15, 1981
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
5
Applicant Total
31
Review Days
38
Basic Information
- Device Name
- ANIS IRRIGATING SPATULA
- K Number
- K810937
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN V. MUELLER
- Date Received
- April 7, 1981
- Decision Date
- May 15, 1981
- Product Code
- HND
- 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 |
|---|---|---|---|
| HND | Spatula, Ophthalmic | FDA class 1 | Ophthalmic |
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| K854568 | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP | Dec 2, 1985 | Substantially Equivalent |
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