| Device Classification Name |
warmer, irrigation solution |
||||
|---|---|---|---|---|---|
| 510(k) Number | K023283 | ||||
| Device Name | 1075LD HUSH-SLUSH | ||||
| Original Applicant |
|
||||
| Original Contact | steve hannes | ||||
| Classification Product Code |
|
||||
| Date Received | 10/01/2002 | ||||
| Decision Date | 11/13/2002 | ||||
| Decision |
substantially equivalent (SESE) |
||||
| 510k Review Panel |
General & Plastic Surgery |
||||
| statement |
statement |
||||
| Type | Traditional | ||||
| Reviewed by Third Party | No | ||||
| Combination Product |
No |