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FDA 510(k) Application Details - K003195
Device Classification Name
System, Delivery, Allergen And Vaccine
More FDA Info for this Device
510(K) Number
K003195
Device Name
System, Delivery, Allergen And Vaccine
Applicant
GREER LABORATORIES, INC.
639 NUWAY CIRCLE, N.E.
P.O. BOX 800
LENOIR, NC 28645-0800 US
Other 510(k) Applications for this Company
Contact
GERALD FRIESEN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LDH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/12/2000
Decision Date
12/13/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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