510(k) K882575
- Device
- Distometer
- Applicant
- HAGG-STREIT SERVICE, INC.
- 510(k) number
- K882575
- Product code
- HMM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-01
- Date received
- 1988-06-22
- Regulation
- 886.1190
- Classification name
- Distometer
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM PENDERGAST
- Address
- 1050 Connecticut Ave., NW Washington DC US 20036 20036
FDA Registration Numbers#
- 3003998208
- 2518410
- 9617474
- 1418300
- 3009555447
- 3009555440
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HMM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K873440 | RULE, PUPILLARY | Allegheny Plastics, Inc. | 1987-09-21 |