510(k) K821080
- Device
- HAND KERATOSCOPE
- Applicant
- Medical Equipment Designs, Inc.
- 510(k) number
- K821080
- Product code
- HLR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-24
- Date received
- 1982-04-19
- Regulation
- 886.1350
- Classification name
- Keratoscope, Battery-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005785090
- 3021343245
- 3010675798
- 1926681
- 3017249918
- 3004095901
- 8043441
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HLR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901553 | SURG-K SURGICAL KERATOMETER | The Sanborn Co. | 1990-07-20 |
| K882902 | QRK 100, QUALITATIVE RING KERATOSCOPE | Technitex, Inc. | 1988-08-04 |
| K882618 | JEDMED/POLACK KERATOSCOPE HS/SL | Gamut Ent. | 1988-07-13 |
| K864639 | REUSABLE SURGICAL KERATOSCOPE | Jedmed Instrument Co. | 1986-12-29 |
| K854054 | PLACIDO DISC | Cutler Medical Instruments | 1985-12-27 |
| K830008 | KARICKHOFF KERATOSCOPE | Surgidev Corp. | 1983-01-26 |