| Device Classification Name |
System, Communication, Powered
|
| 510(k) Number |
K931855 |
| Device Name |
LIGHTWRITER |
| Applicant |
| Zygo Corp. |
| 16260 SW Upper Boones Ferry Rd. |
| P.O. Box 1008 |
|
Portland,
OR
97207
|
|
| Applicant Contact |
LAWRENCE H WEISS |
| Correspondent |
| Zygo Corp. |
| 16260 SW Upper Boones Ferry Rd. |
| P.O. Box 1008 |
|
Portland,
OR
97207
|
|
| Correspondent Contact |
LAWRENCE H WEISS |
| Regulation Number | 890.3710 |
| Classification Product Code |
|
| Date Received | 04/13/1993 |
| Decision Date | 05/10/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|