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| FDA Medical Device #2954299 | |||
| Device Classification Name | Pad, Heating, Powered | ||
| 510(k) Number | K072534 | ||
| Device Name | BIO-MAT 2000 | ||
| Applicant | RICHWAY INTL., INC. 1314 South king St., Suite 520 Honolulu, HI 96814 |
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| Contact | Leroy Klima | ||
| Regulation Number | 890.5740 | ||
| Classification Product Code | IRT | ||
| Date Received | 09/07/2007 | ||
| Decision Date | 02/08/2008 | ||
| Decision | Substantially Equivalent (SE) | ||
| Classification Advisory Committee | Physical Medicine | ||
| Review Advisory Committee | Physical Medicine | ||
| Statement/Summary/Purged Status | Summary only | ||
| Summary | Summary | ||
| Type | Traditional | ||
| Reviewed by Third Party | No | ||
| Expedited Review | No |
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