| Device Classification Name |
Anesthesia Conduction Kit
|
| 510(k) Number |
K961075 |
| Device Name |
MEDCARE REGIONAL ANETHESIA KIT |
| Applicant |
| Medcare Medical Group, Inc. |
| 234 Old Homestead Hwy. |
|
East Swanzey,
NH
03446
|
|
| Applicant Contact |
CRAIG J BELL |
| Correspondent |
| Medcare Medical Group, Inc. |
| 234 Old Homestead Hwy. |
|
East Swanzey,
NH
03446
|
|
| Correspondent Contact |
CRAIG J BELL |
| Regulation Number | 868.5140 |
| Classification Product Code |
|
| Date Received | 03/18/1996 |
| Decision Date | 09/06/1996 |
| Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|