| Device Classification Name |
Wrap, Sterilization
|
| 510(k) Number |
K932036 |
| Device Name |
LACERATION TRAY |
| Applicant |
| Clinipad Corp. |
| 66 High St. |
| P.O. Box 387 |
|
Guilford,
CT
06437
|
|
| Applicant Contact |
PATRICIA STAWARZ |
| Correspondent |
| Clinipad Corp. |
| 66 High St. |
| P.O. Box 387 |
|
Guilford,
CT
06437
|
|
| Correspondent Contact |
PATRICIA STAWARZ |
| Regulation Number | 880.6850 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 04/27/1993 |
| Decision Date | 12/13/1993 |
| Decision |
Substantially Equivalent - Kit
(SESK) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|