Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K970102
Device Classification Name
Filter, Bacterial, Breathing-Circuit
More FDA Info for this Device
510(K) Number
K970102
Device Name
Filter, Bacterial, Breathing-Circuit
Applicant
PROMEDIC, INC.
6329 WEST WATERVIEW CT.
MCCORDSVILLE, IN 46055-9501 US
Other 510(k) Applications for this Company
Contact
PAUL E DRYDEN
Other 510(k) Applications for this Contact
Regulation Number
868.5260
More FDA Info for this Regulation Number
Classification Product Code
CAH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/13/1997
Decision Date
06/24/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact