Device Classification Name |
unit, cautery, thermal, battery-powered
|
510(k) Number |
K771189 |
Device Name |
HOT TEMP CAUTERY |
Applicant |
EDWARD WECK, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
EDWARD WECK, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.4115
|
Classification Product Code |
|
Date Received | 07/01/1977 |
Decision Date | 07/11/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|