| Device Classification Name |
Unit, Operative Dental
|
| 510(k) Number |
K891006 |
| Device Name |
QUICK-TIP (DENTAL OPERATORY UNIT) |
| Applicant |
| Bernard S Esrock |
| Cave Springs Office Center |
| Suite Q, 4200 N Cloverleaf Dr. |
|
St. Charles,
MO
63301
|
|
| Applicant Contact |
S ESROCK,DDS |
| Correspondent |
| Bernard S Esrock |
| Cave Springs Office Center |
| Suite Q, 4200 N Cloverleaf Dr. |
|
St. Charles,
MO
63301
|
|
| Correspondent Contact |
S ESROCK,DDS |
| Regulation Number | 872.6640 |
| Classification Product Code |
|
| Date Received | 02/28/1989 |
| Decision Date | 05/24/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|