FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KELMAN DIPSTICK
K Number: K792383
·
Decision Dec 11, 1979
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
6
Applicant Total
41
Review Days
15
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Basic Information
- Device Name
- KELMAN DIPSTICK
- K Number
- K792383
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
- Date Received
- November 26, 1979
- Decision Date
- December 11, 1979
- Product Code
- HOE
- 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 |
|---|---|---|---|
| HOE | Caliper, Ophthalmic | FDA class 1 | Ophthalmic |
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