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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holding Chambers, Direct Patient Interface
510(k) Number K101348
Device Name AGACHAMBER SPACER
Applicant
AGAPLASTIC IND. COM. LTDA.
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA F GRIFFIN
Correspondent
AGAPLASTIC IND. COM. LTDA.
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Correspondent Contact MARIA F GRIFFIN
Regulation Number868.5630
Classification Product Code
NVP  
Date Received05/13/2010
Decision Date 04/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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