Device Classification Name |
bougie, urological
|
510(k) Number |
K822711 |
Device Name |
ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL |
Applicant |
PARKER LABORATORIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
PARKER LABORATORIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5520
|
Classification Product Code |
|
Date Received | 09/07/1982 |
Decision Date | 11/03/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|