FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLANT, EYE SPHERE
K Number: K781356
·
Decision Aug 21, 1978
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
38
Applicant Total
14
Review Days
14
Basic Information
- Device Name
- IMPLANT, EYE SPHERE
- K Number
- K781356
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- MCGHAN MEDICAL CORP.
- Date Received
- August 7, 1978
- Decision Date
- August 21, 1978
- Product Code
- HPZ
- 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | FDA class 2 | Ophthalmic |
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Other Clearances by MCGHAN MEDICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K873476 | MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS | Sep 11, 1987 | Substantially Equivalent |
| K873475 | MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS | Sep 11, 1987 | Substantially Equivalent |
| K870754 | MCGHAN TISSUE EXPANDER FILL SYSTEM | Mar 31, 1987 | Substantially Equivalent |
| K864185 | MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN | Dec 24, 1986 | Substantially Equivalent |
| K864184 | MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN | Dec 24, 1986 | Substantially Equivalent |
| K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER | Jul 23, 1986 | Substantially Equivalent |
| K854794 | MCGHAN INTEGRAL VALVE TISSUE EXPANDER | Dec 24, 1985 | Substantially Equivalent |
| K853014 | MCGHAN TISSUE EXPANDER FILL KIT | Sep 18, 1985 | Substantially Equivalent |
| K843704 | MCGHAN TISSUE EXPANDER | Oct 31, 1984 | Substantially Equivalent |
| K781087 | MEDICAL GRADE SILICONE ELASTOMER TUBING | Nov 22, 1978 | Substantially Equivalent |