510(k) K781650
- Device
- TERRY KERATOMETER
- Applicant
- CLIFFORD M. TERRY, M.C.
- 510(k) number
- K781650
- Product code
- HJA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-10-17
- Date received
- 1978-09-27
- Regulation
- 886.1350
- Classification name
- Photokeratoscope
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 2918630
- 3009337401
- 1836161
- 3013403214
- 9611516
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HJA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901523 | VKG 1000, VIDEO KERATOGRAPH | The Sanborn Co. | 1990-06-27 |
| K893968 | VKG 2000 VIDEO KERATOMETER | Technitex, Inc. | 1989-09-11 |
| K842128 | AMERICAN MEDICAL OPTICS PHOTOKERATO | American Medical Optics | 1984-08-07 |
| K830290 | DORC CONTACT/PHOTO DERATOSCOPE | Jedmed Instrument Co. | 1983-03-09 |
Legacy Summary#
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FDA Review#
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