Device Classification Name |
Barrier, Synthetic, Intraoral
|
510(k) Number |
K982865 |
Device Name |
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT |
Applicant |
ATRIX LABORATORIES, INC. |
2579 MIDPOINT DR. |
FORT COLLINS,
CO
80525 -4417
|
|
Applicant Contact |
ELYSE WOLFF |
Correspondent |
ATRIX LABORATORIES, INC. |
2579 MIDPOINT DR. |
FORT COLLINS,
CO
80525 -4417
|
|
Correspondent Contact |
ELYSE WOLFF |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 08/13/1998 |
Decision Date | 09/08/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|