Device Classification Name |
Retainer, Surgical
|
510(k) Number |
K870809 |
Device Name |
MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 |
Applicant |
ADEPT-MED INTL., INC. |
3293 SARATOGA LN. |
PO BOX 1777 |
CAMERON PARK,
CA
95682
|
|
Applicant Contact |
KATHLEEN QUIGLEY |
Correspondent |
ADEPT-MED INTL., INC. |
3293 SARATOGA LN. |
PO BOX 1777 |
CAMERON PARK,
CA
95682
|
|
Correspondent Contact |
KATHLEEN QUIGLEY |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 03/03/1987 |
Decision Date | 03/19/1987 |
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
|
Recalls |
CDRH Recalls
|
|
|