Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K972633
Device Classification Name
Sponge, Ophthalmic
More FDA Info for this Device
510(K) Number
K972633
Device Name
Sponge, Ophthalmic
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
183 PROVIDENCE,
NEW LONDON TNPK
NORTH STONINGTON, CT 06359 US
Other 510(k) Applications for this Company
Contact
GEORGE P KORTEWEG
Other 510(k) Applications for this Contact
Regulation Number
886.4790
More FDA Info for this Regulation Number
Classification Product Code
HOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/14/1997
Decision Date
12/17/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact