| Device Classification Name |
bone grafting material, synthetic |
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|---|---|---|---|---|
| 510(k) Number | K992216 | |||
| Device Name | BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE | |||
| Applicant |
|
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| Applicant Contact | judith e o’grady | |||
| Correspondent |
|
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| Correspodent Contact | judith e o’grady | |||
| Regulation Number | 872.3930 | |||
| Classification Product Code |
|
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| Date Received | 07/01/1999 | |||
| Decision Date | 07/26/1999 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Dental |
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| 510k Review Panel |
Dental |
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| summary |
summary |
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| Type | Special | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |
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| Recalls | CDRH Recalls |