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FDA 510(k) Application Details - K101522
Device Classification Name
Lubricant, Patient
More FDA Info for this Device
510(K) Number
K101522
Device Name
Lubricant, Patient
Applicant
ULTRA SEAL CORPORATION
521 MAIN STREET
NEW PALTZ, NY 12561 US
Other 510(k) Applications for this Company
Contact
JAMES DAVIS
Other 510(k) Applications for this Contact
Regulation Number
880.6375
More FDA Info for this Regulation Number
Classification Product Code
KMJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2010
Decision Date
12/23/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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