Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device. |
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Classification Name | composite cultured skin |
Generic Name | pbd |
Regulation Number | 878.4024 |
Applicant |
Ortec International, Inc. |
3960 broadway, 2nd floor |
new yoir, NY 10032 |
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HDE Number | BH991300 |
Supplement Number | 3 |
Date Received | 08/02/2001 |
Decision Date | 10/16/2001 |
Product Code | |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
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