| 510(k) Number |
K862804 |
| Device Name |
SPUNGUARD HOSPITAL COVERALL |
| Applicant |
| Kimberly-Clark Corp. |
| 1400 Holcomb Bridge Rd. |
|
Roswell,
GA
30076
|
|
| Applicant Contact |
CYNTHIA E SMITH |
| Correspondent |
| Kimberly-Clark Corp. |
| 1400 Holcomb Bridge Rd. |
|
Roswell,
GA
30076
|
|
| Correspondent Contact |
CYNTHIA E SMITH |
| Date Received | 07/22/1986 |
| Decision Date | 08/11/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|