| 510(k) Number |
K880048 |
| Device Name |
BLADE, SURGICAL PREP RAZOR STRAIGHT |
| Applicant |
| Crescent Corp. |
| 1310 Majestic Dr. |
|
Fremont,
OH
43420
|
|
| Applicant Contact |
CURTIS RUTTER |
| Correspondent |
| Crescent Corp. |
| 1310 Majestic Dr. |
|
Fremont,
OH
43420
|
|
| Correspondent Contact |
CURTIS RUTTER |
| Classification Product Code |
|
| Date Received | 01/06/1988 |
| Decision Date | 03/04/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|