Device Classification Name |
Speculum, Ent
|
510(k) Number |
K772385 |
Device Name |
THIN-BLADED NASAL SPECULUM |
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 | 878.1800
|
Classification Product Code |
|
Date Received | 12/27/1977 |
Decision Date | 01/17/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|