FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FYODOROV COLLAGEN CORNEAL SHIELD
K Number: K862315
·
Decision Jan 7, 1987
Classifications
1
FEI Numbers
14
Registration Numbers
15
Same Product Code
18
Applicant Total
5
Review Days
203
Basic Information
- Device Name
- FYODOROV COLLAGEN CORNEAL SHIELD
- K Number
- K862315
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL TECHNOLOGY DEVELOPMENT CORP.
- Date Received
- June 18, 1986
- Decision Date
- January 7, 1987
- Product Code
- MOE
- 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 |
|---|---|---|---|
| MOE | Collagen Corneal Shield | FDA class 1 | Ophthalmic |
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Other Clearances by MEDICAL TECHNOLOGY DEVELOPMENT CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K941488 | DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER | Nov 30, 1994 | Substantially Equivalent |
| K863727 | FIXATION INSTRUMENTS | Oct 31, 1986 | Substantially Equivalent |
| K863725 | CATARACT DIAMOND KNIFE | Oct 31, 1986 | Substantially Equivalent |
| K863726 | INSTRUMENT STERILIZATION TRAY | Oct 14, 1986 | Substantially Equivalent |