FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RELIANCE 1379
K Number: K853359
·
Decision Sep 24, 1985
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
6
Applicant Total
279
Review Days
43
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Basic Information
- Device Name
- RELIANCE 1379
- K Number
- K853359
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4855
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Dentsply Intl.
- Date Received
- August 12, 1985
- Decision Date
- September 24, 1985
- Product Code
- HRJ
- 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 |
|---|---|---|---|
| HRJ | Table, Instrument, Powered, Ophthalmic | FDA class 1 | Ophthalmic |
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