| Device Classification Name |
gown, surgical
|
|---|
| 510(K) Number |
K121998 |
|---|
| Models |
96010X/86010X,
96020X/86020X,
96030X/86030X
|
| Device Name |
HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED |
|---|
| Applicant |
| CHANGZHOU HOLYMED PRODUCTS CO LTD |
| 528 changwu road south |
| wujin district |
|
changhou,
|
|
| Contact |
alan yu |
| Regulation Number | 878.4040
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/10/2012 |
|---|
| Decision Date | 12/20/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
General & Plastic Surgery
|
|---|
| Review Advisory Committee |
General Hospital
|
|---|
| statement |
statement
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
