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Trade Name | SPIRATION VALVE SYSTEM (INCLUDING AIRWAY SIZING KIT) |
Classification Name | one-way air-leak valve |
Generic Name | one-way air-leak valve |
Applicant |
Gyrus ACMI, Inc. |
6675 185th avenue ne |
redmond, WA 98052 |
|
HDE Number | H060002 |
Supplement Number | S006 |
Date Received | 07/28/2014 |
Decision Date | 12/16/2014 |
Product Code | |
Advisory Committee |
Anesthesiology |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the post-approval study protocol. |