Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K960101
Device Classification Name
More FDA Info for this Device
510(K) Number
K960101
Device Name
ISLAND BIOSURGICAL BOLSTER
Applicant
ISLAND BIOSURGICAL, INC.
18 MEADOW LN.
MEREER ISLAND, WA 98040-5340 US
Other 510(k) Applications for this Company
Contact
HUNTER A MCKAY
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OTN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/11/1996
Decision Date
12/16/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact