FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHARLES IRRIGATING FUNDUS CONTACT LENS
K Number: K760949
·
Decision Nov 11, 1976
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
7
Applicant Total
48
Review Days
10
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Basic Information
- Device Name
- CHARLES IRRIGATING FUNDUS CONTACT LENS
- K Number
- K760949
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1395
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Richard'S Medical Equip., Inc.
- Date Received
- November 1, 1976
- Decision Date
- November 11, 1976
- Product Code
- HJI
- 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 |
|---|---|---|---|
| HJI | Lens, Fundus, Hruby, Diagnostic | FDA class 1 | Ophthalmic |
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Other Clearances by Richard'S Medical Equip., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830793 | PATIENT GUIDED ELBOW & SHOULDER EXERC | Jun 16, 1983 | Substantially Equivalent |
| K823837 | RMC TOTAL KNEE SYSTEM | Mar 29, 1983 | Substantially Equivalent |
| K823726 | SPECTRON CONVERSION ENDOPROSTHESIS CUP | Mar 9, 1983 | Substantially Equivalent |
| K823724 | SPECTRON NECK REPLACEMENT PROSTHESIS | Mar 9, 1983 | Substantially Equivalent |
| K823723 | SPECTRON PROXIMAL FEMORAL PROSTHESIS | Mar 9, 1983 | Substantially Equivalent |
| K823722 | SPECTRON LONG, STRAIGHT FEMORAL PROSTHES | Mar 8, 1983 | Substantially Equivalent |
| K823727 | SPECTRON PRIMARY STEM FEMORAL PROSTHES | Mar 8, 1983 | Substantially Equivalent |
| K830153 | RICHARDS INTRA-ARTICULAR SHAVER BLADES | Feb 28, 1983 | Substantially Equivalent |
| K830154 | COLLES FRACTURE FRAME | Feb 2, 1983 | Substantially Equivalent |
| K823725 | SPECTRON PROTRUSIO CUP | Jan 21, 1983 | Substantially Equivalent |