Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K955362
Device Classification Name
Formalin-Saline
More FDA Info for this Device
510(K) Number
K955362
Device Name
Formalin-Saline
Applicant
INCSTAR CORP.
1990 INDUSTRIAL BLVD.
P.O. BOX 285
STILLWATER, MN 55082 US
Other 510(k) Applications for this Company
Contact
MARY FRICK
Other 510(k) Applications for this Contact
Regulation Number
864.4010
More FDA Info for this Regulation Number
Classification Product Code
IGC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/22/1995
Decision Date
07/24/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PA - Pathology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact